Several standards, regulations, and guidelines outline requirements for implementing a QMS in the manufacturing industry, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, Good Manufacturing Practice (GMP), ISO 22716:2007, ISO 22000:2018, ISO/TS 16943:2009, AS9100D, and others.

These requirements support companies operating in manufacturing industries in developing and implementing effective QMS. Manufacturing industries encompass medical devices, pharmaceuticals, cosmetics, food and beverage, automotive, aviation, space, and defense, among other industries.

The standards, regulations, and guidelines outline requirements for essential QMS processes, such as document control, change control, training management, deviation and nonconformance management, CAPA management, audits management, supplier management, and others.

This article will cover what a QMS for manufacturing is, several QMS requirements based on different manufacturing sectors, primary QMS processes, and the role of QMS software for manufacturing companies.

SimplerQMS offers a fully validated eQMS software (according to GAMP 5) designed specifically for Life Science companies. Book a demo to see how SimplerQMS can help you streamline your quality management processes and ensure compliance.

This article covers the following topics in more detail:

• What is a Quality Management System (QMS) for Manufacturing?
• What are the Relevant QMS Requirements for Manufacturing?
• What are the Primary QMS Processes in Manufacturing?
• What is the Role of QMS Software for Manufacturing Companies?

What is a Quality Management System (QMS) for Manufacturing?

A Quality Management System (QMS) for manufacturing is a structured system of policies, processes, procedures, work instructions, and records designed to manage quality throughout the manufacturing lifecycle. Manufacturing QMS aims to ensure that products comply with regulatory and customer requirements.

The purpose of a QMS in the manufacturing industry is to ensure and enhance product quality and reliability and increase process efficiency. The manufacturing QMS helps reduce waste and increase customer satisfaction and business profitability.

Key QMS processes in manufacturing include document control, change management, training management, product management, deviation and nonconformance management, CAPA management, complaint management, audit management, supplier management, risk management, and equipment management, among others.

Traditionally, QMS processes have been managed in a paper-based format, involving manual documentation, physical storage, and in-person audits. The paper-based QMS is time-consuming, prone to errors, and challenging to maintain consistently across large companies.

In contrast, an Electronic Quality Management System (eQMS) offers a digital platform to automate and streamline the management of quality processes. An eQMS provides automated workflows, improves data integrity, facilitates accessibility, and supports compliance.

SimplerQMS provides a comprehensive eQMS solution tailored to meet the specific needs of Life Science companies. SimplerQMS is designed to streamline workflows, improve efficiency, and support compliance with stringent regulatory requirements in the Life Science industries.

Our eQMS provides integrated QMS modules for document control, product management, equipment management, CAPA management, audit management, supplier management, and much more, allowing seamless work.

What are the Relevant QMS Requirements for Manufacturing?

Manufacturing quality management systems are governed by numerous QMS requirements to ensure that products comply with regulatory and customer requirements. Strict requirements for manufacturing are essential to establish and uphold a QMS that ensures uniform and high-quality processes and products.

QMS requirements for manufacturing vary depending on factors such as industry, location, product type, and specific additional requirements.

QMS Requirements for General Manufacturing

The relevant QMS requirement applicable to general manufacturing is ISO 9001:2015.

ISO 9001:2015

ISO 9001:2015 is an international standard that specifies requirements for a quality management system. ISO 9001:2015 enables companies to demonstrate their ability to consistently provide products and services in compliance with customer and regulatory requirements.

Below are six ISO 9001:2015 sections to exemplify the requirements for QMS.

• Documented information
• Operational planning and control
• Management review
• Design and development of products and services
• Monitoring, measurement, analysis, and evaluation
• Improvement

ISO 9001:2015 helps organize a QMS, foster customer and management satisfaction, implement continuous improvement, and reduce costs.

QMS Requirements for Medical Device Manufacturing

Relevant QMS requirements that apply to medical device manufacturing are presented further.

• ISO 13485:2016
• FDA 21 CFR Part 820 (Quality System Regulation – QSR)
• European Union (EU) Regulation 2017/745 (Medical Device Regulation – MDR)
• Good Manufacturing Practice (GMP), including EU GMP, US GMP, WHO GMP, and national GMPs

ISO 13485:2016

ISO 13485:2016 is an international regulatory standard that defines requirements for a quality management system in companies providing medical devices and related services. ISO 13485:2016 is applicable when a company needs to demonstrate the ability to consistently comply with customer and regulatory requirements.

ISO 13485:2016 outlines specific requirements for a QMS in the design, development, production, installation, and servicing of medical devices. The ISO 13485:2016 standard focuses on the safety of the end-user and the efficacy of the medical device.

Having an ISO 13485:2015 compliant QMS helps ensure that medical device manufacturers comply with customer and regulatory requirements and improve product quality and safety.

FDA 21 CFR Part 820 (Quality System Regulation)

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a regulation established by the United States Food and Drug Administration (FDA). The 21 CFR Part 820 defines the requirements for a medical device quality management system.

The 21 CFR part 820 aims to ensure the consistent production and control of medical devices, ensuring the safety and effectiveness of those products.

The 21 CFR Part 820 regulation outlines specific requirements for the design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices sold or distributed in the United States.

EU Regulation 2017/745 (Medical Device Regulation)

EU regulation 2017/745, the Medical Device Regulation (MDR), is a regulation by the European Union to ensure the safety of end-users and the efficacy of medical devices.

The EU MDR specifies the requirements for medical device design, manufacture, clinical performance, post-market surveillance, and more across EU member states. Having an MDR-compliant quality management system helps ensure compliance with the requirements for medical device manufacturing, improving product safety and quality while reducing the risk of non-compliance.

The MDR Article 10 outlines the general obligations of QMS manufacturers in the medical device industry, including product realization, reporting of serious incidents, and risk management, among others.

Good Manufacturing Practice (GMP) for Medical Device Manufacturing

Good Manufacturing Practices (GMP) are regulations, standards, and guidelines designed to ensure the uniform and high-quality production and control of products.

GMPs are established by various governments and organizations, such as the European Union and the World Health Organization (WHO). Fortunately, these GMP standards are highly similar.

GMP covers various aspects of manufacturing, including cleanliness, equipment verification, process validation, and documentation. A QMS must meet GMP requirements to enable companies to achieve and maintain product quality and safety.

Examples of GMP standards include US GMP, EU GMP, and WHO GMP, among others.

US GMP for Medical Device Manufacturing

US GMP stands for the United States Good Manufacturing Practice.

The US GMP refers to the requirements set by the FDA to ensure the quality, safety, and efficacy of medical devices, pharmaceuticals, biologics, food, and cosmetics manufactured in the United States.

The FDA outlines specific QMS requirements for medical device manufacturers under 21 CFR Part 820. The 21 CFR Part 820 regulation sets forth the Current Good Manufacturing Practice (CGMP) requirements for medical devices.

EU GMP for Medical Device Manufacturing

EU GMP stands for European Union Good Manufacturing Practice. The EU GMP guideline helps ensure the quality and safety of medicinal products, medical devices, food, and cosmetics.

In the European Union, medical device manufacturers are required to comply with EU GMP under the MDR. These GMP requirements ensure the production of medical devices with high and uniform safety and quality.

Compliance with the MDR and obtaining CE Marking are essential for manufacturers to market and sell medical devices across the 30 countries within the European Economic Area (EEA).

WHO GMP for Medical Device Manufacturing

The WHO GMP are the GMP requirements set forth by the World Health Organization (WHO). The WHO GMP helps ensure products are consistently produced and controlled in compliance with quality standards appropriate to their intended use.

WHO GMP outlines requirements that are broadly applicable to various medical products, including medical devices and pharmaceuticals. The WHO GMP specifies requirements for everything that directly or indirectly affects the product’s safety and quality, including personnel, materials, premises, and methods.

Other National GMPs for Medical Device Manufacturing

Various countries have their own GMP requirements. National GMP often aligns with international standards but may have additional specific regulations and guidelines.

Manufacturers exporting to different countries must comply with the respective GMPs.

QMS Requirements for Pharmaceutical Manufacturing

Relevant QMS requirements that apply to pharmaceutical manufacturing are presented below.

• ICH Q10
• PIC/S GMP
• Good Manufacturing Practice (GMP), including EU GMP, US GMP, WHO GMP, and others.

ICH Q10

ICH Q10 is a guideline by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH Q10 guideline describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System (PQS).

The ICH Q10 provides a comprehensive framework for establishing and maintaining the PQS throughout the product lifecycle. ICH Q10 aims to enhance the quality and availability of medicines worldwide in the interest of public health.

Implementing the ICH Q10 pharmaceutical quality system across the product lifecycle encourages innovation and continuous improvement and strengthens the link between pharmaceutical development and manufacturing processes.

PIC/S GMP

The PIC/S GMP is the GMP guideline developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for medicinal products.

PIC/S GMP is designed to promote harmonized standards for the quality assurance of medicinal products in the pharmaceutical industry worldwide.

The PIC/S GMP is similar to ICH Q10 and EU GMP in various aspects of pharmaceutical manufacturing. All these requirements aim to ensure that medicinal products are consistently produced and controlled in compliance with the appropriate requirements for their intended use.

Good Manufacturing Practice (GMP) for Pharmaceutical Manufacturing

Good manufacturing practices for pharmaceutical manufacturing are the regulations, standards, and guidelines that ensure the quality, safety, and efficacy of medicinal products.

These requirements ensure the consistent production and control of pharmaceutical products to comply with quality standards appropriate for their intended use.

Pharmaceutical manufacturing GMPs are enforced by regulatory agencies such as the US FDA and the European Medicines Agency (EMA).

US GMP for Pharmaceutical Manufacturing

The US GMP for pharmaceutical manufacturing is outlined in the FDA 21 CFR Part 210 and FDA 21 CFR Part 211 regulations.

FDA 21 CFR Part 210 specifies the minimum Current Good Manufacturing Practices (CGMP) for manufacturing, processing, packing, or holding of drugs. The 21 CFR Part 210 aims to ensure that drug products are safe, have identity and strength, and meet the indicated quality and purity characteristics.

FDA 21 CFR Part 211 provides more specific CGMP requirements for the production of finished pharmaceuticals. The 21 CFR Part 211 outlines the requirements necessary to ensure the quality, purity, strength, and identity of finished drug products.

The 21 CFR Part 211 covers principles applicable to the pharmaceutical industry, including several requirements related to the following areas.

• Personnel
• Buildings and facilities
• Equipment
• Control of components
• Drug product containers and closures
• Production and process controls
• Laboratory controls
• Records and reports
• Handling of complaints
• And more.

EU GMP for Pharmaceutical Manufacturing

The EU GMP guideline outlines the rules governing medicinal products in the EudraLex Volume 4.

EU GMP provides basic requirements for the manufacture of medicinal products for human and veterinary use, in addition to several specific annexes. EU GMP serves as a comprehensive resource to help pharmaceutical manufacturers maintain uniform and high quality throughout the production process.

EudraLex Volume 4 specifies the requirements for various aspects of pharmaceutical manufacturing, including facilities, equipment, personnel, documentation, quality control, distribution, and more.

Pharmaceutical companies operating within the EU or seeking to market their products in EU member states must comply with the requirements outlined in EudraLex Volume 4.

WHO GMP for Pharmaceutical Manufacturing

The WHO GMP aims to ensure that pharmaceutical products are made consistently and controlled according to suitable quality standards for their intended use and as needed for marketing approval.

GMP focuses on reducing risks in pharmaceutical production, especially related to preventing mix-ups between different products and ensuring accurate labeling.

WHO GMP also provides a foundation for creating national guidelines for GMP for biological products.

Other National GMPs for Pharmaceutical Manufacturing

Different countries have specific GMP requirements. National GMP can follow international requirements and also include specific national rules and recommendations.

Pharmaceutical manufacturers exporting to different countries must comply with the corresponding GMP requirements.

QMS Requirements for Cosmetics Manufacturing

Relevant QMS requirements that apply to cosmetics manufacturing are ISO 22716:2007 and Regulation (EC) 1223/2009 (EU Cosmetics Regulation).

ISO 22716:2007

ISO 22716:2007 standard outlines the requirements for the manufacturing processes of cosmetics. ISO 22716:2007 helps ensure cosmetic production, control, storage, and shipment.

ISO22716:2007 establishes a framework for implementing GMP guidelines to define the activities that enable companies to obtain a product that meets defined characteristics.

Regulation (EC) 1223/2009 (EU Cosmetics Regulation)

The Regulation (EC) No 1223/2009, also known as the EU Cosmetics Regulation, establishes the requirements within the European Union governing the safety, production, and labeling of cosmetic items.

The EU cosmetics regulation specifies that products must undergo rigorous testing to ensure their safety for human use under expected conditions. Companies must ensure their cosmetics comply with the EU cosmetics regulation requirements before they can be sold in the EEA market.

QMS Requirements for Food and Beverage Manufacturing

Relevant QMS requirements that apply to food and beverage manufacturing are the Global Food Safety Initiative (GFSI) and ISO 22000:2018.

The Global Food Safety Initiative (GFSI)

The Global Food Safety Initiative (GFSI) is a collaboration between various stakeholders in the food industry, including retailers, manufacturers, food service companies, and others. The GFSI helps ensure food safety standards for businesses and provides people with access to safe food.

The GFSI operates as a benchmarking organization that sets criteria for food safety management systems, which are recognized globally. GFSI approves several food safety standards covering farming, packaging, storage, and distribution.

GFSI outlines several principles and requirements related to food safety across the supply chain. GFSI includes requirements for personal hygiene and operational practices similar to GMPs. Hazard analysis and critical control points (HACCP) principles are also included in GFSI requirements, which help identify and control food safety skills.

GFSI encourages continuous improvement, improves food safety and customer loyalty, and supports regulatory compliance.

ISO 22000:2018

ISO 22000:2018 is an international standard that specifies requirements for food safety management. ISO 22000:2018 standard aims to support companies involved in the food chain to plan, implement, operate, maintain, and update a Food Safety Management System (FSMS).

ISO 22000:2018 outlines elements that must be included in an effective FSMS, for example:

• Interactive communication across the company.
• Documentation to be included in the management system.
• HACCP principles that help identify, prevent, and remove food safety hazards.

QMS Requirements for Automotive Manufacturing

The relevant QMS requirement applicable to automotive manufacturing is IATF 16949:2016.

IATF 16949:2016

IATF 16949:2016 is an international standard that outlines the QMS requirements for the design, development, production, installation, and service of automotive-related products.

IATF 16949:2016 standard focuses on continuous improvement, defect prevention, and reduction of variation and waste in the supply chain. The IATF 16949:2016 shares similarities with ISO 9001:2015 in terms of QMS core principles and structure.

IATF 16949 standard includes additional automotive-specific requirements tailored to the unique needs and challenges of the automotive industry, such as control of repaired products, automotive product-related software, and engineering specifications.

QMS Requirements for Aviation, Space, and Defense Manufacturing

Relevant QMS requirements that apply to aviation, space, and defense manufacturing are the AS9100, AS9110, and AS9120.

AS9100

AS9100 is an internationally recognized quality management standard for the aerospace industry. AS9100 specifies requirements for establishing, implementing, and maintaining a quality management system to ensure the consistency and quality of aerospace products and services.

AS9100 applies to all aerospace organizations, from design and manufacturing to maintenance and stockist distributors.

AS9100 incorporates all the ISO 9001:2015 requirements and supplements them with additional criteria tailored to the aviation, space, and defense sectors, such as counterfeit parts prevention and reporting.

AS9110 and AS9120

AS9110 and AS9120 are quality management system standards for aerospace maintenance companies and aerospace distributors, respectively.

These standards outline specific requirements for companies involved in maintenance, repair, and overhaul activities and aerospace parts distribution.

What are the Primary QMS Processes in Manufacturing?

The primary quality management system processes in manufacturing are listed below. This article focuses on manufacturing, so the design and development process is not included.

• Document Control
• Change Control
• Training Management
• Deviation and Nonconformance Management
• CAPA Management
• Complaint Management
• Audit Management
• Supplier Management
• Risk Management
• Equipment Management
• Product Management

Examples of how SimplerQMS software can streamline each QMS process will be provided.

Document Control

Document control encompasses creating, reviewing, approving, storing, distributing, and revising documents within the quality system.

The document control process maintains the integrity of manufacturing operations and helps achieve compliance with regulatory and customer requirements. Effective document control prevents errors and inconsistencies in product quality by ensuring all personnel access up-to-date and accurate documents.

An eQMS with robust document control capabilities, like SimplerQMS, streamlines the document control process. The eQMS facilitates control of document versions, easy access to currently in-use documents, and the secure storage and retrieval of in-use and obsolete documents.

Automated notifications related to document release, review, and approval activities reduce time and effort in document creation and approval cycles. Additionally, eQMS solutions provide capabilities for electronic signatures, time-stamped audit trails, and controlled printing.

Change Control

Change control is the process of managing all changes within manufacturing companies related to processes, procedures, products, documents, templates, and others. Change control involves evaluating, approving, implementing, and monitoring changes to ensure they are controlled and documented.

Change control prevents disruptions and defects that arise from uncontrolled changes, ensuring that any modification is thoroughly assessed.

Electronic QMS, such as SimplerQMS, provides capabilities to streamline the change control process. The eQMS automates the workflow of change requests, from initiation through review, approval, implementation, and effectiveness assessment.

SimplerQMS change control module facilitates monitoring change status and related documentation updates with automatic notifications and task reminders. The eQMS software enables real-time collaboration across departments, ensuring all employees participate in the change management process.

Training Management

Training management is the process of managing employee training and development programs, from initial planning and resource coordination to execution and evaluation. A well-established training management process ensures that the workforce possesses the necessary skills and knowledge to perform their tasks.

Training management ensures that employees are aware of their roles and responsibilities within the company. Effective training programs contribute to risk mitigation and foster a culture of continuous improvement by empowering employees with the knowledge necessary to manage risks.

The eQMS streamlines training management, automating tasks such as assigning training activities, sending email notifications, conducting training effectiveness assessments, and tracking training progress.

The training management capabilities in SimplerQMS can enhance scheduling, tracking, and follow-up of training gaps and missed deadlines, eliminating delays for employees to acquire applicable knowledge.

Deviation and Nonconformance Management

Deviation and nonconformance are events within a process or procedure in which the result does not comply with the established requirements.

Inefficient management of deviations and nonconformance can result in non-compliance with internal policies, procedures, or regulatory and customer requirements. A well-structured deviation and nonconformance management process helps companies identify the root cause of issues and prevent potential problems in product or service quality.

Quality management software streamlines the management of deviations and nonconformance management, facilitating timely investigation and resolution. With eQMS solutions, like SimplerQMS, companies efficiently manage the entire lifecycle of a deviation or nonconformance, from initial detection through to closure and effectiveness assessment.

The features an eQMS provides in the context of nonconformance and deviation management include automated workflows for recording, reviewing, and closing deviations and nonconformances. QMS software integrates with other connected QMS processes, such as CAPA (Corrective and Preventive Actions), to ensure comprehensive issue resolution.

CAPA Management

CAPA (Corrective and Preventive Action) management is a process aimed at preventing issues, such as deviations and nonconformances, from occurring. CAPA process identifies and addresses the root cause of issues by systematically investigating discrepancies in procedures and products.

Companies implement corrective actions to address current issues and preventive actions to prevent the recurrence of similar issues.

The CAPA process typically comprises several key steps: identification, evaluation, investigation, analysis, action plan, implementation, and follow-up.

Implementing QMS software with CAPA management capabilities streamlines the entire CAPA process, from identifying issues to resolving and closing them. The eQMS automates workflows, improves accountability, and helps ensure CAPA-related tasks are completed on time.

With an eQMS, like SimplerQMS, companies can efficiently manage all steps of the CAPA process, including root cause analysis, action planning, action implementation, effectiveness checks, and closures.

Complaint Management

A complaint is an expression of dissatisfaction made by a customer to a company regarding its product or service. Complaint management involves the systematic handling, investigation, and resolution of customer complaints.

Customer complaint management is essential for companies due to the impact on product quality, safety, and customer trust. Complaint management is a diagnostic tool to identify and rectify underlying issues, with each complaint acting as a symptom.

Implementing eQMS with complaint management capabilities facilitates the efficient recording, tracking, and resolution of complaints. With the SimplerQMS complaint management module, companies can automate task assignments, track complaint progress, and maintain a centralized repository of complaint records and related documentation.

The software enables easy linkage of complaints to specific products and lot numbers and integration with other modules, such as CAPA, facilitating comprehensive issue resolution and continuous improvement.

Audit Management

Audit management is a systematic process that manages all activities related to auditing, from planning and scheduling to conducting and documenting audit findings. Audits assess the effectiveness of the QMS and compliance with regulatory and customer requirements and help identify areas for improvement.

With regular audits, companies verify compliance with internal and external requirements, identifying gaps in quality management practices. Audit findings can lead to corrective and preventive actions, mitigating potential risks.

An eQMS facilitates the scheduling and planning of audits (regulatory, supplier, internal), the assignment of auditors, and the tracking of audit findings and recommendations.

SimplerQMS audit management module streamlines the creation of audit checklists, allows the compilation of audit findings electronically, and manages follow-up activities more efficiently. The eQMS ensures that audit records are securely stored and easily accessible for review and analysis.

Supplier Management

Supplier management involves selecting, evaluating, and monitoring suppliers to ensure they comply with relevant regulatory and customer requirements.

Effective supplier management ensures that materials and components sourced from suppliers meet quality specifications, reducing the risk of product failures, recalls, and non-compliance issues. The supplier management process also ensures strong supplier relationships and supply chain continuity and supports the company’s overall quality objectives.

eQMS software streamlines supplier qualification processes and the handling of supplier-related documentation, including contracts, quality agreements, and required certificates.

Through SimplerQMS, companies can consolidate supplier data, simplifying the process of evaluations and audits. The supplier management module automatically notifies about re-evaluations or necessary follow-up actions according to a set schedule, helping ensure compliance and quality assurance.

Risk Management

Risk management is a systematic process of identifying, assessing, prioritizing, and mitigating risks that can affect product quality and safety. Risk management involves analyzing issues, evaluating potential impacts, and developing strategies to manage or minimize adverse effects.

The risk management process typically comprises five essential steps.

1. Risk Identification
2. Risk Assessment
3. Risk Control
4. Risk Review
5. Risk Communication

Risk management is essential in highly regulated industries to ensure products and services maintain compliance with regulatory and customer requirements. By identifying and assessing quality risks early on, measures can be taken to prevent or mitigate risks.

eQMS with risk management capabilities facilitates the systematic documentation, analysis, and reporting of risks.

SimplerQMS risk management module provides automated workflows to ensure that risk-related tasks are promptly addressed. Notification and reminders ensure decision-makers are informed of significant risk changes. The eQMS offers the capability to link risk-related documents to related processes, documents, and CAPAs, providing a comprehensive view of risk management activities.

Equipment Management

Equipment management is the process of managing all aspects of a manufacturing facility’s equipment. Equipment management ensures that equipment is calibrated, maintained, and operated in a manner that supports product quality, safety, and compliance.

Equipment management includes scheduling regular maintenance, calibration, validation, and ensuring that equipment operates within specified parameters.

Properly managed equipment reduces the risk of production downtime, product quality issues, and non-compliance with regulatory and customer requirements.

eQMS allows the scheduling of maintenance and calibration activities, tracks the history of equipment performance, and manages documentation related to equipment validation and operation procedures. Equipment can be directly linked to specific standard operating procedures (SOPs), work instructions, and maintenance tasks.

SimplerQMS offers notifications for upcoming maintenance or calibration tasks, ensuring these critical activities are not overlooked. The equipment management module also allows for the centralization of equipment records, making it easier to access and review historical data, maintenance logs, and compliance documents.

Product Management

Product management is the systematic process of managing a product’s lifecycle, from design to manufacturing. Product management helps ensure products are safe and comply with customer and regulatory requirements.

Product management involves tasks such as product design, development, production scheduling, manufacturing, and quality control.

An eQMS with product management capabilities streamlines product management processes by centralizing product data, enabling effective collaboration across departments, and tracking product manufacturing stages.

SimplerQMS offers product management capabilities by streamlining the organization of product-related information. The QMS software allows the relation of documents to products, product lots, equipment, suppliers, customers, documents, and more. Companies can use product release notes to consolidate documents related to the manufacturing process and products through hyperlinks.

What is the Role of QMS Software for Manufacturing Companies?

The eQMS software for manufacturing companies streamlines and improves quality management processes.

eQMS software centralizes and automates the management of quality processes, supports compliance with regulatory requirements, improves efficiency, and helps maintain product safety and quality.

QMS software allows the management of QMS processes, including document control, change management, CAPA management, training management, audit management, supplier management, risk management, and equipment management, among others.

A key capability of QMS software is the integration with other software applications, such as ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), PLM (Product Lifecycle Management), SCM (Supply Chain Management) systems, and more.

SimplerQMS is a ready-to-use eQMS tailored specifically for Life Sciences companies, including pharmaceutical, medical devices, biotechnology, laboratories, CROs, and CMOs. SimplerQMS streamlines all QMS processes with automated workflows and interlinked documents, ensuring seamless and efficient workflow.

SimplerQMS’ comprehensive support of QMS processes helps companies to comply with various QMS requirements in the Life Sciences industry, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, GMP, EU MDR, ICH Q10, among others.

SimplerQMS is fully validated according to ISPE GAMP5. The system is kept in a validated state, with continuous updates whenever new versions or changes are introduced, ensuring compliance and readiness for audits and inspections.

Experience how SimplerQMS streamlines QMS processes and supports your Life Science company’s needs. Book a demo and speak with our Quality Solution Consultants experts.

The post Quality Management System (QMS) for Manufacturing appeared first on SimplerQMS.

Companies use eQMS primarily to streamline processes, ensure regulatory compliance, and improve overall quality management across their operations.

The eQMS software supports quality teams in managing and tracking quality management-related processes, such as document control, change management, training management, supplier management, and many others, in a centralized and efficient manner.

Companies utilizing eQMS benefit from improved customer and regulatory compliance, streamlined processes, and increased efficiency.

When choosing an eQMS, companies should first assess the specific requirements applicable to them, thoroughly research and compare QMS software vendors, participating in demo meetings. Companies must ensure that the QMS software aligns with the company’s needs and objectives.

This article discusses what an eQMS stands for, what is included in an eQMS, why companies adopt eQMS, its functions, and its benefits. Additionally, the article briefly explains how to choose the right eQMS solution, offering key considerations, and provides examples of the best QMS software for Life Sciences.

SimplerQMS offers a fully GAMP 5-validated eQMS software designed specifically for Life Science companies. Book a demo to see how our solution streamlines quality management processes and helps ensure compliance.

Explore the specific topics covered in this article:

• What is an eQMS?
• Why Do Companies Use an eQMS System?
• What Does eQMS Software Do?
• What Are The Benefits of eQMS Software?
• What Makes a Good eQMS Software?
• How to Choose an eQMS Software?
• The 9 Best QMS Software Solutions for Life Sciences

What is an eQMS?

An electronic Quality Management System (eQMS) is a digital platform designed to centralize, automate, and streamline quality-related processes within a company. The eQMS encompasses features such as document control, change management, training management, Corrective and Preventive Actions (CAPA), risk management, audits management, and others.

An eQMS is the digital format of a quality management system, offering a modern approach to managing quality management processes. Other formats of QMS include traditional paper-based QMS relying on physical documentation and hybrid systems that combine digital and paper-based formats of quality management.

Companies facing challenges with paper-based and hybrid QMS, like lost documents, outdated records, and inefficient processes, can benefit from implementing an eQMS. An eQMS aids companies in overcoming paper-based and hybrid system challenges by automating quality management processes and simplifying the tracking and management of data, documents, and workflows.

Typically, an eQMS is deployed as a cloud-based quality management system. The cloud-based nature of eQMS makes it accessible to authorized users anywhere, at any time, and on authorized devices with an internet connection.

While cloud-based eQMS are popular solutions, an on-premise option also exists, allowing companies to host the system’s infrastructure in a way that best fits their needs and preferences.

Electronic QMS supports companies in achieving and maintaining regulatory compliance. It enables companies to monitor compliance with industry regulations, standards, and guidelines and proactively identify and address issues.

What is the Difference Between Electronic QMS (eQMS) and Enterprise QMS (EQMS)?

While eQMS stands for Electronic Quality Management System, the term can occasionally be associated with Enterprise Quality Management System (EQMS).

Electronic Quality Management System (eQMS) refers to a digital platform designed to automate and streamline quality management processes.              

Enterprise Quality Management System (EQMS) is the quality management software large enterprise-size companies utilize to manage their quality management processes. Many larger companies and enterprises have adopted eQMS as their quality system due to the difficulties of maintaining a manual QMS at scale.

Enterprises can utilize one or more eQMS software solutions depending on their needs. Enterprises utilize specific functionalities within the eQMS, such as site functions, which enable organizations to restrict access to specific documents based on user roles assigned to individual sites.

SimplerQMS provides broad QMS process support and scalability, being an Enterprise Quality Management System provider. SimplerQMS eQMS software offers the ability to manage different sites. Each site can access documents specific to them while following the same predefined workflows across the organization.

Why Do Companies Use an eQMS System?

Companies use an eQMS system to streamline quality management processes, reduce costs, increase efficiency, and help ensure regulatory compliance.

Implementing an eQMS is beneficial for companies that need to comply with comprehensive customer and regulatory requirements. For instance, eQMS benefits companies in the Life Science industry, such as pharmaceutical, biotechnology, and medical devices. The eQMS provides support for QMS processes to ensure continuous improvement and compliance with requirements.

Life Science companies must comply with regulations, standards, and guidelines that outline the requirements for the Quality Management System (QMS).

What Does eQMS Software Do?

The electronic QMS software automates and streamlines the handling of documents, policies, procedures, and processes essential for ensuring product safety and effectiveness. The eQMS software provides a centralized repository for all documents and data, making it easy to manage quality processes and workflows.

Electronic QMS streamlines quality processes and facilitates compliance with requirements by offering features like document control, change management, training management, audit management, supplier management, and many more. The eQMS enhances operational efficiency, improves efficiency, increases collaboration among team members, and helps ensure compliance.

A suitable eQMS should seamlessly integrate with a company’s existing operations, ensuring a harmonious alignment with established quality management processes.

An effective eQMS should optimize quality management processes by enabling companies to:

• Efficiently create, modify, review, approve, and retire documents.
• Securely approve documents using electronic signatures.
• Manage document versions and control access based on user roles and permissions.
• Monitor and handle quality events like nonconformances, customer complaints, audit findings, and CAPAs.
• Simplify and guide through various quality management processes, including employee training management, change control, design control, risk management, equipment calibration, supplier management, and more.
• Generate reports and analyze quality data to recognize trends and areas for ongoing improvement.
• Strategically plan, schedule, execute, and document quality audits.
• Assist in maintaining compliance with applicable requirements.

What Are The Benefits of eQMS Software?

The benefits of implementing QMS software include the following.

• Improved Compliance: eQMS software helps ensure that companies comply with customer and regulatory requirements. The software’s predefined workflows guide users through the correct process steps. All actions are automatically documented in a time-stamped audit trail.
• Improved Process Efficiency: By streamlining workflows and automating repetitive tasks, eQMS software improves process efficiency, reducing the need for manual work.
• Improved Product Quality: eQMS software helps enforce consistent execution of quality procedures throughout predefined workflows. Electronic QMS helps achieve higher and more uniform product quality and fewer deviations and nonconformances.
• Enhanced Communication: The eQMS software fosters collaboration and communication among team members. The software provides a centralized platform for sharing information, feedback, and updates.
• Cost Reduction: By reducing quality issues and streamlining processes, eQMS platform helps lower operational costs. eQMS also enables companies to optimize resource allocation with data-driven decision-making.
• Audit Readiness: eQMS software maintains accurate and up-to-date histories of quality-related activities, making companies well-prepared for audits and inspections. The eQMS facilitates access to documentation, document retrieval, evidence of compliance, and traceability, ensuring smooth audit processes.
• Data-Driven Decision-Making: The eQMS software provides quality data, and KPI reports that allow companies to identify quality performance, trends, and areas for improvement. eQMS software enables companies to make informed decisions based on quality data, driving continuous improvement and strategic planning.

What Makes a Good eQMS Software?

Below are the key factors contributing to good eQMS software.

• QMS Process Support: The software offers comprehensive support for all quality management processes.
• Computer System Validation (CSV): Fully validated eQMS software ensures compliance with requirements regarding computer system validation.
• Regulatory Compliance: Good QMS software supports compliance with industry-specific requirements.
• Flexible Implementation Process: A flexible implementation process enables companies to tailor the software implementation to their specific needs.

Additional details on each factor contributing to a good eQMS software are presented below.

QMS Process Support

The QMS software provides comprehensive support for all quality management processes.

A good QMS software supports processes such as:

• Document Control
• Change Control
• Training Management
• Supplier Management
• Design Control
• Risk Management
• Audit Management
• Nonconformance and Deviation Management
• CAPA Management
• And more.

Computer System Validation (CSV)

Fully validated eQMS software ensures compliance with regulatory requirements, safeguards data integrity, and helps maintain product quality and safety.

Computer System Validation (CSV) is the process used to ensure a computerized system meets its intended use consistently. Validation of quality management system software is a requirement when the software is used to manage regulated processes.

The validation of QMS software involves three key stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These protocols ensure that the software is correctly installed, functions as intended, and performs effectively in real-world scenarios.

SimplerQMS offers a fully validated eQMS solution in accordance with ISPE GAMP 5. The software remains in a validated state at all times, with SimplerQMS managing all validation and revalidation tasks.

Regulatory Compliance

QMS software supports compliance with regulations, guidelines, and standards that outline QMS requirements applicable to companies operating in specific industries, such as the Life Science industries. Good QMS software facilitates quality processes to ensure adherence to regulatory requirements.

For example, for pharmaceutical companies, specific requirements include compliance with guidelines for pharmaceutical quality systems like ICH Q10 and Good Manufacturing Practices (GMP) regulations such as FDA 21 CFR Part 211.

In the medical device industry, requirements encompass standards for quality management systems, such as ISO 13485:2016, current Good Manufacturing Practices (cGMP) like FDA 21 CFR Part 820, as European regulations such as Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Additionally, common QMS requirements can apply to several industries, including the general quality management systems standard ISO 9001:2015. Other requirements QMS software solutions often comply with include the cybersecurity standard ISO 27001:2022 and the regulation for electronic signatures and records, such as FDA 21 CFR Part 11, as well as requirements for using computerized systems EU Annex 11.

Compliance With FDA 21 CFR Part 11

The QMS software that is compliant with the 21 CFR Part 11 regulation follows a comprehensive framework for managing electronic records and signatures in a secure and compliant system.

The United States Food and Drug Administration (FDA) 21 CFR Part 11 is a regulation that aims to ensure electronic records and electronic signatures’ integrity, reliability, and authenticity.

SimplerQMS offers 21 CFR Part 11-compliant eQMS software specifically designed for Life Science companies. The eQMS software includes controls for electronic signatures and records, including management of passwords and identification codes, automatic linking of signatures to records, and comprehensive audit trails, among many other functionalities.

Compliance With EU Annex 11

By complying with EU Annex 11, an eQMS demonstrates its reliability, security, and integrity in managing electronic records and signatures. The eQMS effectively safeguards data, maintains audit trails, and upholds the authenticity of electronic documentation.

The EU Annex 11 is the European Union guideline establishing the requirements for computerized systems within GMP-regulated activities. EU Annex 11 includes requirements for electronic records and electronic signatures.

SimplerQMS provides eQMS software designed for Life Science companies and complies with EU Annex 11. The eQMS complies with computerized system requirements, including system validation, generation of audit trails, appropriate personnel training, secure data storage, records retrieval, and security measures.

Flexible Implementation Process

A good eQMS software is characterized by a flexible implementation process, which empowers companies to tailor the software implementation according to their specific needs and timelines.

A flexible implementation process allows companies to customize the implementation phases by prioritizing the implementation of certain QMS modules and accommodating upcoming audits or inspection deadlines.

For example, some companies need to fast-track implementation for upcoming audits, while others prefer a longer implementation period.

Companies focused on manufacturing may prioritize implementing Equipment or Suppliers Management modules, while companies dealing with recorded issues prioritize implementing the CAPA (Corrective and Preventive Actions) Management module.

SimplerQMS’s Customer Success team collaborates with customers in kick-off meetings to outline a personalized plan for QMS software implementation. SimplerQMS offers a phased implementation process. Each phase focuses on implementing and providing training for specific QMS modules, which can be customized to the needs of each customer.

How to Choose an eQMS Software?

Choosing an eQMS software involves several steps to ensure that the selected solution aligns with the company’s needs and objectives.

The steps companies can follow to choose an eQMS software are mentioned below.

1. Assess Your Requirements: Identify all relevant regulations, standards, and guidelines the company needs to comply with. Outline the functionalities the QMS software needs to have to comply with the applicable requirements.
2. Research and Compare QMS Software Vendors: Gather information about vendors and their solutions through Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP). Compare the chosen QMS software and vendor features side-by-side.
3. Select Relevant QMS Software Vendors:  Based on information from RFI, RFQ, and RFP, choose vendors that best align with the company’s needs. Consider vendor reputation and customer reviews.
4. Get Demos and Have Meetings: Request demos from shortlisted vendors to see how the software operates and assess its suitability. Schedule follow-up meetings to explore specific QMS modules and clarify doubts.
5. Consider Getting a Trial:  Request a trial period to evaluate the software’s functionality, usability, and compatibility with existing workflows.
6. Shortlist QMS Software Vendors:  Narrow down the QMS software options based on the information gathered from demos, meetings, and trials.
7. Get Demonstration of Specific Use Cases:  Request demonstrations tailored to address specific use cases and scenarios, ensuring the software addresses daily operations.
8. Negotiate With Shortlisted QMS Providers: Negotiate with shortlisted vendors for favorable terms regarding pricing, contract terms, implementation timelines, and any additional needs.
9. Make Final Decision:  Carefully consider all information, including demos, trials, and negotiations, to choose the QMS software that best aligns with the company’s needs and offers the most comprehensive solution.

Simplify your decision-making process by downloading our complimentary QMS Software Comparison Template.

Utilize the template to perform a comprehensive side-by-side comparison of different QMS software solutions, assessing vendor features, functionalities, and pricing structures tailored to your specific requirements.

What Are the Key Considerations When Choosing an eQMS Software?

Below are some considerations for selecting the right QMS software.

Be aware that choosing QMS software involves a comprehensive series of steps and considerations to ensure the final decision aligns with the company’s needs and objectives.

• Quality Management System Needs: Clearly outline the company’s quality management system needs. Identify specific quality processes, compliance requirements, and features an eQMS must address.
• Training and Support: Consider the training options and support provided by an eQMS vendor. Adequate training ensures that users can maximize the system’s capabilities, while reliable support is essential for addressing any issues.
• Validation and Certification: Look for eQMS software that has undergone validation processes and follows the Good Automated Manufacturing Practice (GAMP), such as ISPE GAMP 5.
• Additional Features: Evaluate the supporting technology offered by the QMS. Supporting technology may include real-time data dashboards, mobile accessibility, a document editing interface, integration possibilities, and reporting solutions.
• Cloud-Based Deployment: Consider opting for a cloud-based eQMS. Cloud solutions offer accessibility, flexibility, and often include regular updates without requiring extensive on-premise infrastructure.

When Is the Right Time to Consider an eQMS?

Life Science companies often consider implementing an eQMS once they have established or are actively developing their quality management system and associated documentation.

Determining the precise moment to implement a QMS software is complex.

The five main reasons to consider an eQMS are listed below.

• Improving communication across departments
• Automating QMS processes
• Improving compliance efforts
• Gaining better visibility into quality data
• Seeking scalability

While finding the ideal time is challenging, companies gain greater benefits by implementing an eQMS sooner rather than later. Early adoption of QMS software allows companies to build a robust foundation for ensuring quality and compliance.

How Much Time Does It Take to Implement QMS Software?

The comprehensive QMS software solution is typically implemented within a timeframe of 5 to 6 weeks.

The duration of QMS software implementation may vary based on factors such as the number of documents requiring creation or migration, as well as the availability of time resources within the company.

For example, SimplerQMS software implementation follows a structured phase approach that focuses on deploying distinct QMS modules. The SimplerQMS implementation allows for customizable QMS module sequences based on individual requirements, with all implementation activities and associated training provided at no extra charge.

How Much Does an eQMS Cost?

The cost of the software may vary depending on factors such as the number of QMS modules, licenses, and add-ons like implementation and training, among others.

For instance, QMS software prices usually start at $13,000 for a company with 5 to 10 employees. The price range for QMS software can vary from $25,000 to $100,000 for companies with 50 to 200 employees.

SimplerQMS provides an all-inclusive solution that includes all QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting within the yearly license cost.

The pricing structure of SimplerQMS is determined by the number of licenses acquired. The license price covers all features and services, eliminating the need for additional costs.

Visit our pricing page for detailed information regarding costs and the features and services provided.

The 9 Best QMS Software Solutions for Life Sciences

The 9 best QMS software solutions for Life Sciences are listed below. The best QMS software solution for the Life Sciences list results from the expertise of our quality specialists, feedback from customers and partners, and extensive research.

1. SimplerQMS

SimplerQMS is a cloud-based quality management system (QMS) software specifically designed for companies in the Life Sciences industry. SimplerQMS offers comprehensive support for all QMS processes, including document control, training management, change management, non-conformance and deviation management, CAPA management, design control, audit management, equipment management, and more.

SimplerQMS software seamlessly integrates with the Microsoft suite, allowing for easy document editing and collaboration using familiar tools such as Word, Excel, and PowerPoint.

The software is fully validated according to GAMP 5. SimplerQMS helps companies comply with various regulatory requirements related to Life Sciences, such as GxP, ISO 13485:2016, 21 CFR Part 11, EU Annex 11, and others.

SimplerQMS is available as an all-inclusive annual subscription with pricing based on the number of user licenses. The subscription includes all QMS modules, system implementation, training, validation, hosting, and support. Users appreciate the software’s ease of use and good value for the price, and customer support is often praised for its expertise and responsiveness.

2. Qualio

Qualio offers a cloud-based quality management platform specifically designed for growing Life Science companies in medical devices, pharmaceuticals, and biotechnology.

The software provides core QMS functionalities like document management, risk management, and training. Qualio helps ensure compliance with requirements such as FDA 21 CFR Part 11, ICH Q10, GxP, ISO 13485:2016, and more. While pre-validated according to GAMP 5, some additional customer-side validation is required.

Qualio is known for its ease of use, efficient implementation process, and helpful customer support. It integrates with various popular apps but lacks integration with Microsoft Office. Pricing is tiered based on features and user licenses.

3. MasterControl

MasterControl offers QMS solution catering to various industries, including pharmaceuticals, medical devices, and food and beverage. Primarily targeted at large enterprises, MasterControl manages core quality processes like document control, training, and nonconformance management, among others.

MasterControl software is FDA 21 CFR Part 11 compliant and supports various requirements, such as FDA regulations, ISO requirements, CLIA, EU MDR, and more.  The software automates GAMP 5 processes and offers a patented Validation Excellence Tool (VxT) for user-friendly software validation. 

MasterControl is known for its robust document management features and easy integration with other software applications, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Manufacturing Execution Systems (MES), and more. Pricing is tiered based on features, users, and additional services.

4. TrackWise

TrackWise offers both on-premise (TrackWise) and cloud-based (TrackWise Digital) QMS solutions with AI-powered features for proactive quality management.

The software caters to various industries, including pharmaceuticals, medical devices, and food and beverage. TrackWise centralizes all QMS processes for improved efficiency, compliance, and risk reduction. 

TrackWise supports Life Science requirements, such as FDA 21 CFR Part 11, 211, and 820, EU Annex 11, MDR, ICH Q9, Q10, and Q11, GxP, and ISO standards. The software provides a computer system validation package for each software release.

Pricing is customized based on user needs and requires contacting sales for a quote. Users appreciate the high level of configurability and integration with other business systems like Salesforce.

5. Ideagen Quality Management

Ideagen Quality Management is a modular eQMS solution catering to diverse industries like life sciences, manufacturing, and healthcare.

Ideagen offers a comprehensive suite of QMS modules like document control, audit management, CAPA, and others, all integrated and streamlined with automated workflows. The software uses familiar tools like Microsoft Office for document editing.

Ideagen, in collaboration with CompliancePath, provides end-to-end validation services. While basic validation is included, full validation requires additional investment.

User praise focuses on the system’s document control, CAPA management features, and exceptional customer support. Pricing remains undisclosed but can be purchased as a perpetual license or subscription.

6. Greenlight Guru

Greenlight Guru is a cloud-based QMS platform designed specifically for the MedTech industry. Greenlight Guru offers comprehensive QMS modules, including document management, training, and risk management, among others, alongside specialized features for design control and clinical trials.

Greenlight Guru stands out for its ease of use and risk-based computer system validation package, aligning with FDA regulations and best practices. Users benefit from in-app document editing and a native traceability matrix generation tool.

The software offers tiered subscription plans with dedicated support and on-demand training resources. Medical device industry experts guide implementation, and it can be completed within 2-8 weeks.

Greenlight Guru is praised for its intuitive interface and well-structured workflows, particularly for design control and risk management, making it a strong choice for MedTech companies.

7. Dot Compliance

Dot Compliance offers a pre-configured, cloud-based QMS built on the Salesforce platform. Dot Compliance software provides features like interconnected QMS modules, facilitating management across various quality processes. The software offers an AI assistant for data insights.

Dot Compliance allows for document management with Microsoft Office integration, keeping document editing in familiar applications.

The software supports compliance with FDA regulations, GMP, EU MDR, ISO 9001:2015, 13485:2016, 14791:2019, 27001:2022, and more. Dot Compliance helps ensure GAMP 5 compliance with a fully executed validation package.

Dot Compliance offers tiered pricing with various features and modules depending on the chosen plan, making it a scalable solution for growing Life Science companies.

8. QT9

QT9 offers a cloud-based quality management system that attends companies of all sizes across various industries, including Life Sciences, manufacturing, and food and beverage.

The software offers over 23 built-in QMS modules, including document control, risk management, and training. QT9 supports compliance with various requirements like FDA regulations and ISO standards. The software provides free validation reports (IQ, OQ, PQ) with every update.

QT9 is known for its scalability with a modular pricing structure, unlimited training options, and a free 30-day trial. Customers also appreciate its user-friendly interface and strong integration with their existing technology, especially with its own ERP system.

9. Scilife

Scilife offers a cloud-based quality management platform designed to streamline quality management processes and empower Life Science companies. Scilife provides core QMS modules such as document management, training, CAPA, and others. The software seamlessly integrates Microsoft Office for document editing.

Scilife is validated according to GAMP 5 on the Amazon Web Services (AWS) platform, taking care of most user validation tasks. Scalable pricing with a free plan and tiered options allows companies of all sizes to benefit. Users praise Scilife’s affordability, ease of use, and excellent customer support.

Learn More About SimplerQMS Today

Now that you know all about what eQMS is and some of the best Life Science eQMS software on the market, it is time to evaluate which one is right for your Life Science company.

Let’s take the next step in streamlining your quality management journey today.

You can book a demo with one of our Quality Solution Consultants to discover how SimplerQMS can benefit your company.

The post What is an eQMS? (Plus the 9 Best eQMS for Life Sciences) appeared first on SimplerQMS.

A Quality Management System (QMS) software helps ensure high and uniform quality of products and services in compliance with customer and regulatory requirements. The QMS software provides tools for managing quality-related tasks, such as document control, change management, training management, audit management, and supplier management, among others.

Choosing the right quality management software is essential for optimizing quality processes, ensuring compliance, increasing operational effectiveness, decreasing workload, and reducing costs.

Selecting QMS software requires going through a series of steps and considering various aspects, which will be explained in this article. These steps and considerations are essential for making an informed decision that aligns with the company’s needs and objectives.

SimplerQMS provides comprehensive QMS software designed to meet the unique needs of Life Science companies. Book a demo with our Quality Solution Consultants to learn more.

Table of Contents

• 1. Assess Your Requirements
• 2. Research and Compare QMS Software Vendors
• 3. Select Relevant QMS Software Vendors
• 4. Get Demos and Have Meetings
• 5. Consider Getting a Trial
• 6. Shortlist QMS Software Vendors
• 7. Get a Demonstration of Specific Use Cases
• 8. Negotiate With Shortlisted QMS Providers
• 9. Make Final Decision
• What More to Consider When Selecting QMS Software?

1. Assess Your Requirements

The first step in choosing the right QMS software is a thorough assessment of the company’s specific needs and objectives related to customer and regulatory requirements.

Companies should identify all relevant guidelines, quality standards, and regulations to which they must comply.

The requirements may include general guidelines for computerized systems effectiveness, like ISPE GAMP 5, and general QMS requirements, such as ISO 9001:2015. They may also encompass specific requirements for medical device QMS, such as ISO 13485:2016, pharmaceutical QMS, such as ICH Q10, and medical laboratory competence standards, like ISO 15189:2022, among many others.

Additionally, companies should outline functional requirements, such as the system’s capability to perform specific tasks to ensure the software fulfills all necessary criteria. For instance, the system must be able to generate time-stamped audit trails, be deployed as a cloud-based solution, integrate with other systems, and support compliant electronic signatures.

2. Research and Compare QMS Software Vendors

Companies must gather all relevant information about QMS software vendors and their solutions to make informed decisions.

What Is the Key Information to Request From a Vendor?

The key information to request from a QMS software vendor includes product features, pricing structure, implementation process, support services, and other details. Information is typically obtained through Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP).

Below is a description of what RFI, RFQ, and RFP entail:

• Request for Information (RFI): An RFI is a formal document used to gather general information from vendors about products, services, features, and pricing models.
• Request for Quotation (RFQ): An RFQ is a solicitation document used to request specific pricing information from potential vendors for a defined set of product features, number of users, license types, and implementation scope. RFQ allows for cost comparisons and helps determine budget feasibility.
• Request for Proposal (RFP): An RFP is a formal document sent to shortlisted vendors to submit proposals detailing how they would meet the requirements outlined by the requesting company. RFP typically includes information on implementation plans, support services, deliverables, number of users, chosen license type, timelines, and pricing.

For an easier QMS vendor comparison, download our QMS Software Comparison Template.

The template enables the comparison of QMS software solutions and their features side by side, providing a comprehensive overview of available options.

3. Select Relevant QMS Software Vendors

Companies should identify and choose QMS software vendors whose solutions align with the company’s specific needs and requirements. These needs and requirements should be clearly defined through the processes of RFI, RFQ, and RFP.

When selecting QMS software vendors, it is important to consider vendor reputation and customer feedback and review from reputable review platforms such as G2, Gartner, TrustRadius, Capterra, Software Suggest, GetApp, and others.

Customer feedback and reviews offer insights into the real-world experiences of other users, providing valuable information on the QMS software’s reliability, usability, and customer support. Assessing the vendor’s reputation helps gauge their credibility, track record, and commitment to customer satisfaction.

For example, customers praise SimplerQMS for its intuitive interface and excellent customer support. Customers of SimplerQMS also emphasize great value for money and ease of use.

It is important to note that each QMS software vendor may have reviews that highlight its unique characteristics. These reviews can provide valuable insights for companies when selecting a vendor for further analysis.

4. Get Demos and Have Meetings

Companies should request a system demonstration from selected QMS vendors so they can view firsthand how the QMS software operates. The demonstration provides an opportunity to assess the user interface, functionality, and suitability of the QMS software for the company’s needs. Before scheduling a demonstration, some vendors may conduct initial discovery and qualification calls.

Multiple follow-up meetings may be necessary to explore specific software modules more deeply and ensure a comprehensive understanding of the QMS software’s capabilities.

In a typical demo meeting with SimplerQMS, a Quality Solution Consultant provides an overview of the software’s features and functionalities. The overview is followed by a live demonstration showcasing key aspects such as document control, change management, and training management modules. After the demonstration, the discussion typically shifts to pricing and licensing options. Follow-up meetings can be scheduled to explore specific modules in more detail based on the company’s requirements.

5. Consider Getting a Trial

Companies can consider requesting a free trial of the QMS software to evaluate its functionality, usability, and compatibility with their workflows and processes before committing.

The trial period allows users to explore the features, test various functionalities, and assess how the software complies with specific customer and regulatory requirements.

SimplerQMS offers a sandbox trial so that potential customers can experience the software firsthand before committing. The trial period allows users to explore the features and functionalities of SimplerQMS in a simulated environment.

Many SimplerQMS customers have found value in conducting a sandbox trial before making their final decision. The trial allows potential customers to thoroughly evaluate the QMS software and its capabilities in a risk-free setting.

6. Shortlist QMS Software Vendors

Companies should narrow the list of QMS software vendors to those that best meet the company’s needs and requirements. At this stage, a company choosing a QMS software may have shortlisted 3 to 5 QMS vendors based on information gathered from demos, meetings, and trials.

Companies should assess QMS vendors and software beyond the initial cost and consider the solution’s overall value to their quality management processes.

Additionally, companies can ask for references and case studies from similar companies operating in their industry. Customer references provide insights into the real-world experiences and benefits of using QMS software.

7. Get a Demonstration of Specific Use Cases

Companies often ask shortlisted QMS software vendors to provide specific demonstrations tailored to address unique use cases and scenarios relevant to the company’s daily operations.

Exploring how the QMS software addresses specific use cases allows for a more detailed assessment of the software’s capabilities and suitability.

For example, a medical device manufacturer may request a demonstration of how the QMS software manages the design control process, including design verification and validation.

Alternatively, a pharmaceutical company may request a demonstration of how the QMS software handles deviation management processes, including a direct escalation to CAPA (Corrective and Preventive Actions).

At SimplerQMS, customers often request in-depth sessions to fully understand the QMS software’s capabilities. These sessions involve a comprehensive overview of the various modules and functionalities, such as document control, change management, and training, among others. Such in-depth sessions may last 2 to 3 hours and accommodate multiple stakeholders.

8. Negotiate With Shortlisted QMS Providers

Companies should negotiate with the shortlisted QMS providers to secure favorable terms that align with the company’s budget and requirements.

To ensure a comprehensive negotiation process, it is essential to address various relevant aspects, such as the ones presented below.

• Pricing: Negotiate the pricing structure to ensure it aligns with the company’s budget and provides value for money.
• Contract Terms: Discuss and agree upon the terms of the contract, including payment schedules, termination clauses, and renewal terms.
• Implementation Timelines: Establish realistic timelines for implementing a new QMS software. Consider factors such as data migration, training, system configuration, as well as upcoming audits, or other internal projects.
• Support Services: Define the level of support services the vendor provides, including availability, response times, and escalation procedures for addressing technical issues.
• Customization Needs: Discuss the availability of additional features and customization that may not be included in the base price but are crucial for the company’s specific needs.
• Total Cost of Ownership (TCO): Calculate the TCO of the QMS software, including initial costs, ongoing maintenance, support fees, and any additional charges for customization or upgrades.
• Service Level Agreements (SLAs): Determine the SLAs that define the level of service expected from the vendor, such as uptime guarantees, response times for support queries, and resolution times for issues.
• Training and Support Options: Evaluate the vendor’s training and support options, including on-site training, online resources, and technical support staff availability.
• Vendor Roadmap: Assess the vendor’s roadmap for future upgrades and improvements to ensure the software remains relevant and aligned with the market needs.
• Legal and Compliance Issues: Address key legal and compliance issues during negotiation, such as data privacy laws, regulatory requirements, and intellectual property rights.
• Contract Review: Emphasize the importance of a detailed review of the contract by legal counsel before signing.

9. Make Final Decision

Companies should choose the QMS software vendor that best aligns with their requirements. The choice is made after considering all gathered information, including demonstrations, trials, and negotiations. The ideal QMS software provider offers a complete solution to streamline quality management.

Additional aspects to consider when making the final decision include the following.

• Achieving Consensus Among Key Stakeholders: Companies must ensure alignment and consensus among key stakeholders, including quality management and IT departments. This ensures the chosen QMS software adequately addresses cross-functional needs and requirements.
• Review of the Proposed Implementation Plan: Thoroughly assess the proposed implementation plan, including timelines, resource requirements, and milestones. Such implementation plan assessment helps determine its feasibility and alignment with organizational capabilities and constraints.
• Evaluation of Scalability: Companies should evaluate the software’s ability to scale and adapt to future business growth and evolving quality management needs. Ensure that it can accommodate expanding operations and increased complexities over time.
• Flexibility of Contract Terms: Examine the flexibility of contract terms, including provisions for contract adjustments, renewals, and termination. Ensure the agreement remains adaptable to changing circumstances and needs.
• Final Evaluation Meeting: Organize a final evaluation meeting with the decision-making team to discuss all findings, assessments, and analyses. Facilitate a comprehensive review and ensure everyone is aligned before making the final decision.

The following sections will delve deeper into various aspects to consider during the QMS software selection process. The sections below elaborate on the features and characteristics of good QMS software, additional factors to consider, questions to ask QMS software vendors and risks of choosing the wrong eQMS.

What More to Consider When Selecting QMS Software?

When selecting QMS software, companies should consider factors that align with their quality management needs and objectives.

Key considerations include the eQMS software’s functionality, customer support, compliance with requirements, and the ability to integrate with other systems, among others.

What Features Should You Look for in QMS Software?

Some of the features companies should look for in QMS software are described below.

• Out-Of-The-Box Workflows: Out-of-the-box workflows are preconfigured workflows that guide users through quality management processes. Preconfigured workflows accelerate system implementation and adoption, help save time, and ensure regulatory compliance and consistency.
• Electronic Signatures: Electronic signatures are digital representations of handwritten signatures used to authenticate documents in electronic format. Modern QMS software must provide FDA 21 CFR Part 11 and EU GMP Annex 11-compliant electronic signatures to enable secure and compliant process control.
• Audit Trails: Audit trails are chronological records that document every action taken within a system. Time-stamped audit trails within the QMS software ensure accountability and data integrity.
• Reminders and Email Notifications: Choose software with automatic reminder and notification functionalities to keep users informed and ensure timely action on tasks.
• Data Visibility: Opt for QMS software that offers data visibility features, including exporting data and generating quality Key Performance Indicator (KPI) reports.
• User Interface and Usability: Prioritize QMS software with an intuitive user interface and usability features to enhance user adoption and productivity.
• Security Features: Look for software with strong security features. Key features include user access control, multi-factor authentication (MFA), and unique user identification (ID). These security features safeguard sensitive information and ensure compliance with data protection requirements.

Moreover, companies must ensure that the QMS software offers all the necessary quality management modules that align with their organizational needs and meet customer and regulatory requirements.

What Characteristics Define Good eQMS Software?

The characteristics of good eQMS software are as follows.

• Software Vendor’s Industry Experience: The QMS software should be provided by a vendor with industry experience. Good eQMS software offers specialized solutions tailored to the unique needs and requirements of specific industries. Choose an eQMS developed by vendors with extensive industry experience relevant to your field. For example, SimplerQMS is designed specifically for the Life Science industry.
• Deployment/Hosting Options: QMS software vendors offer various deployment options to accommodate organizational preferences and requirements, including cloud-based and on-premise hosting. Choose a QMS solution that offers deployment options aligned with your company’s preferences.
• Configuration Possibilities: Some companies need configurable quality management software. In these cases, companies should choose QMS software that allows such flexibility. Select QMS software that effectively supports the workflows and processes within the company.
• Integration Possibilities: Some companies require QMS software integrations with other systems and tools used within the company. Opt for an eQMS solution that seamlessly integrates with existing systems and tools, enabling efficient data exchange and workflow automation.
• Compliance: Good eQMS software supports compliance with the applicable customer and regulatory requirements. Ensure compliance with industry requirements by choosing an eQMS software that complies with FDA and EU regulations, ISO standards, and other relevant requirements.
• Computer System Validation (CSV): Computer System Validation is the process of ensuring that a computerized system functions as intended. Some companies need QMS software validation. These companies should choose a quality management software vendor that provides a validated solution. Validated QMS software should provide documentation and support to demonstrate the QMS software’s validation as required in highly regulated industries.
• Continuous Improvement and Development: Good eQMS software vendors demonstrate a commitment to continuous improvement and development. Vendors regularly update features and functionalities to meet evolving industry needs and technological advancements. Select an eQMS vendor committed to continuous improvement, ensuring the QMS software remains relevant and effective over time.
• Scalability: QMS software should allow for scalability to accommodate organizational growth and changing needs. Invest in scalable eQMS software that can expand alongside the company without sacrificing performance or efficiency.

What Additional Factors Should Be Considered When Selecting QMS Software?

Some additional factors companies should consider when selecting QMS software are mentioned below.

Total Pricing

Consider the Total Cost of Ownership (TOC) for implementing the QMS software. The TOC is the comprehensive assessment of all direct and indirect costs associated with owning and operating a product or system over its entire lifecycle.

The TOC includes upfront fees, recurring costs, any additional expenses associated with customization or integration, and more.

License Model

Evaluate the licensing model of the software to ensure it aligns with the company’s budget and usage requirements.

A flexible license model ensures optimal utilization of resources and maximizing the QMS software’s value proposition.

Hidden Costs

Consider potential hidden expenses associated with paid features. These features can include implementation, training, ongoing support, hosting fees, and additional storage space requirements.

For example, SimplerQMS provides a comprehensive, all-inclusive solution, including implementation, support, training, hosting, and more, all of which are included in the yearly license cost.

Document Migration

Assess the ease and cost of migrating existing documents and data from the company’s current system to the new QMS software.

Document migration poses challenges, particularly during the shift from paper-based to electronic systems, increasing the risk of data loss.

SimplerQMS addresses this concern by assisting customers in seamlessly migrating their existing documents into the system, ensuring a smooth transition and preserving critical data integrity.

Free QMS Templates

Determine if the software vendor offers a free template package for quality management documents and records.

Free QMS templates are useful during the initial stages of building a QMS or when companies want to review their current templates against best practices during QMS software implementation.

Examples of QMS templates that SimplerQMS provides include quality manuals, standard operating procedures (SOPs), work instructions, and forms.

Below are examples of procedures and instructions that SimplerQMS provides to all customers.

• Document Control
• Change Control
• Complaints Handling
• Nonconformance
• CAPAs
• Education and Training
• Purchasing
• And other procedures and instructions.

Below are examples of templates and forms that SimplerQMS provides to all customers.

• Audit Plan Template
• Change Request Form
• Education and Training Plan Template
• Nonconformance Report Template
• Risk Assessment and Control (RAC-FMEA) Form
• CAPA Form
• Customer Complaint Form
• Supplier Review Form
• And other templates and forms.

Implementation Process

Understand the steps involved in implementing the QMS software, including timeline, resources required, and potential disruptions to daily operations. A well-planned and executed QMS software implementation process is crucial for swiftly adopting the solution and unlocking its full value.

The SimplerQMS implementation process takes an average of 6 weeks and follows a structured, phased approach. The eQMS implementation process encompasses a kick-off meeting, system configuration, document creation and migration, and unlimited personnel training. Once configured and trained, the customer transitions to production.

Customer Support

Evaluate the quality and availability of customer support services provided by the software vendor, including response times, channels of communication, level of expertise, and the answer quality.

Responsive and helpful customer support ensures timely assistance to resolve issues, minimizing downtime and optimizing productivity. Effective support also fosters user satisfaction and confidence in the QMS software.

Customers often praise SimplerQMS’s performance, affordability, and exceptional customer service. For instance, a client testimonial on Capterra praised SimplerQMS for delivering the best customer support experience witnessed in 15 years.

User Training

Consider the availability of training resources and programs to ensure users can effectively utilize the QMS software and maximize its benefits.

Evaluate the available training delivery formats, such as video libraries, workshops, live calls, or in-person training sessions, to accommodate various learning preferences.

Inquire about any limitations on training hours and whether additional training can be purchased if needed. Understanding the amount of training available and the flexibility to extend it ensures users can effectively learn how to utilize the software.

SimplerQMS provides comprehensive training through live calls, videos, and written materials. Customers of SimplerQMS can benefit from an unlimited number of training hours.

User Access Restrictions

Determine the software’s capability to restrict user access to sensitive information within the QMS software. User access restrictions ensure data security and compliance with security requirements.

User access control is useful when different user roles have varying authorization levels. User access restrictions limit access to confidential documents or critical quality documentation to authorized personnel with specific permission levels only.

For example, QMS software by SimplerQMS allows for user restrictions based on company site, project, or document confidentiality levels.

Non-Quality Documents

Assess whether the QMS software can be effectively utilized for managing non-quality-related documents, such as HR documents, marketing, and finance management, among others.

Companies can benefit from using modern QMS software that also allows them to manage non-quality documents. Managing both quality and non-quality documents in one system eliminates scattered storage solutions.

SimplerQMS offers non-quality document management. Our eQMS software eliminates the need for additional document management and storage solutions such as SharePoint, Dropbox, or Google Drive.

Localization and Translation

Companies in need of QMS software in a particular language should prioritize QMS solutions that offer multilingual functionality.

Having the system interface translated into the local languages provides global support and promotes user acceptance. A multi-language solution empowers companies with sites in different regions to configure the system according to their specific language, increasing user engagement.

What Questions Should Be Asked When Evaluating QMS Software?

When evaluating QMS Software, companies should consider asking QMS vendors the following questions.

What happens if I do not have an internet connection?

When selecting a cloud-based QMS software, inquire about offline access options or backup plans in case of internet connection issues.

How do the software’s deployment options align with the IT strategy?

Evaluate how the software’s deployment options align with the company’s IT strategy and infrastructure.

Can the software be easily integrated with existing systems?

Assess the software’s compatibility and ease of integration with existing systems and software applications. For example, compatibility with systems like Customer Relationship Management (CRM), Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Manufacturing Execution System (MES), Product Lifecycle Management (PLM), and more.

How does the vendor ensure compliance with the industry’s regulatory requirements?

Request information on how the vendor ensures compliance with relevant industry regulations, standards, and guidelines that outline requirements for QMS and related processes.

QMS software vendors present compliance with requirements using the User Requirement Specification (URS). The URS outlines the specific needs and expectations of the end-users regarding the software’s functionality and features.

The URS involves detailing how the QMS software supports compliance with requirements such as ISO 9001:2015, ISO 13485:2016, MDR, IVDR, EudraLex Volume 4 GMP, FDA 21 CFR Part 11, 211, and 820, and others.

What are the system’s capabilities for growth and scalability to match the business’s expansion?

Inquire about the scalability and growth capabilities of the system to accommodate your business’s expansion plans.

For example, if the company expands internationally or diversifies its product lines, the QMS software must easily scale to support increased users, data volumes, and geographical locations without sacrificing performance.

What Are the Risks Associated With Choosing the Wrong eQMS?

Below are the key risks of choosing the wrong QMS software which can be avoided by following the QMS software selection steps.

It is important to note that companies should perform a risk assessment related to the eQMS. A proper risk assessment identifies potential risks associated with choosing the wrong QMS software and helps define the company’s User Requirements Specification (URS).

Noncompliance With Requirements

Not clearly understanding the company’s customer and regulatory requirements can lead to selecting software that does not address specific compliance and quality management needs.

Utilizing QMS software that is not compliant with applicable requirements can result in regulatory violations, customer dissatisfaction, and increased operational risks. 

Companies should thoroughly document and analyze all applicable requirements to avoid this risk. Companies should also involve key stakeholders from relevant departments to ensure comprehensive coverage of all needs and objectives.

Inefficient Quality Processes

Choosing the wrong eQMS can result in inefficient quality processes. The QMS software may not align with the company’s workflow or lack essential features. Inefficient processes can lead to wasted time, manual workarounds, and reduced productivity.

To avoid this risk, companies should thoroughly assess the QMS software’s compatibility with existing processes. Schedule demos with multiple vendors to explore a diverse range of features, functionalities, and user interfaces, allowing for a more informed comparison and evaluation.

Limited Scalability

An eQMS that lacks scalability can pose risks to companies as they grow and evolve. Without the ability to scale the QMS software to accommodate increasing data volumes, users, or business complexities, companies may face limitations in managing quality processes effectively.

Companies should prioritize eQMS solutions that can accommodate increasing data volumes with additional storage space and expanding user numbers.

Data Security Breaches

Inadequate data security features in the QMS software can increase the risk of data breaches and unauthorized access to sensitive information. Without robust security measures, such as multifactor authentication (MFA) and access controls, companies are vulnerable to cyber threats and data theft.

Companies should select QMS software with robust access controls, multifactor authentication, single sign-on, and a time-stamped audit trail, among other features.

Missing an Industry-Specific eQMS Solution

The absence of tailored demonstrations during the eQMS selection process can lead to the implementation of a system that is not well-suited to your industry’s specific quality management needs.

To avoid this risk, it is essential to provide vendors with detailed use case scenarios that reflect your operational requirements before purchase. Insist on customized demonstrations that address these scenarios to evaluate the effectiveness of an eQMS and ensure it aligns with your specific needs.

Choosing QMS Software That Does Not Support the Whole Company

Failure to include key stakeholders, like the IT department, in the QMS selection process can result in implementing QMS software that does not meet the needs of specific company departments.

Excluding stakeholders may result in resistance to QMS software adoption, implementation challenges, and non-compliance with specific requirements.

Representatives from all relevant departments should be involved in the QMS software selection process to gather input on specific needs and preferences.

How Much Does QMS Software Cost?

The price of QMS software varies depending on several factors, such as the number of users, included QMS modules and features, and the chosen license types and quantity.

QMS software prices usually start at $13,000 for a company with 5 to 10 employees. The price range for QMS software can vary from $25,000 to $100,000 for companies with 50 to 200 employees.

The SimplerQMS pricing structure is based on the number and types of licenses purchased. The yearly license cost includes all QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting.

For detailed pricing information on SimplerQMS features and services, please visit our dedicated pricing page.

What Are the Hidden Costs of QMS Software?

Some of the commonly hidden costs when implementing QMS software are described below in more detail.

• Implementation: Costs associated with setting up and configuring the QMS software to align with the company’s processes.
• Training: Expenses related to training employees on how to use the QMS software effectively.
• Extra modules: Additional costs for implementing QMS modules beyond the basic package.
• Validation: Expenses with validating the QMS software to ensure compliance with regulatory requirements when the vendor does not validate the QMS software.
• Hosting: Charges for hosting the QMS software on a server or cloud platform.
• Storage: Costs related to additional data storage space within the QMS software if needed.
• Document migration: Expenses associated with migrating existing documents and data into the QMS software.
• Support: Costs for ongoing technical support and maintenance provided by the QMS software vendor beyond the initial implementation phase.

SimplerQMS offers a license-based pricing model that includes all QMS modules, implementation, user training, validation, hosting, document migration, and ongoing support for one price, with no hidden costs.

The system offers an adaptable storage solution. It starts with a base 50 GB capacity and allows for the purchase of additional storage if needed. The storage space automatically increases with the purchase of additional user licenses, providing 10 GB per additional Single User License and 30 GB per additional Shared License.

What Are the Best QMS Software Solutions to Choose From?

The best examples of QMS software solutions for Life Science companies are the following.

• SimplerQMS: SimplerQMS is a fully validated QMS software tailored for Life Science companies, offering extensive module options and seamless integration with Microsoft Office.
• Qualio: Qualio is designed for growing Life Science companies and presents a user-friendly web-based document editor.
• MasterControl: MasterControl is ideal for large Life Science enterprises, excelling in comprehensive document control and complying with FDA 21 CFR Part 11 regulation.
• TrackWise: TrackWise is tailored for pharmaceuticals, biotech, and more, featuring AI-driven decision-making for proactive quality management.
• Ideagen Quality Management: With a wide array of modules, Ideagen Quality Management stands out for its Microsoft Office integration and e-learning capabilities.
• Greenlight Guru: Cloud-based and focused on MedTech, Greenlight Guru simplifies document workflows with native editing.
• Dot Compliance: Dot Compliance offers AI-driven insights through its assistant, Dottie AI, for Life Sciences companies.
• QT9: QT9 provides a web-based eQMS with over 23 built-in modules for various industries.
• Scilife: Scilife is a QMS validated on the Amazon Web Services platform that offers comprehensive QMS modules tailored to Life Sciences.

The post How to Choose Quality Management Software? appeared first on SimplerQMS.

The M-Files software can also be used as an Electronic Quality Management System (eQMS).

M-Files provides a flexible and configurable platform that enables companies to manage quality processes, documentation, and compliance requirements efficiently.

M-Files offers features that support the core components of an eQMS, such as document control, process automation, electronic signatures, audit trails, enterprise-level security, and more.

SimplerQMS has utilized M-Files as the foundational platform, configuring and building upon it to create a quality management system software tailored for the Life Sciences industry.

SimplerQMS has leveraged M-Files to develop integrated Life Science QMS modules, streamlining document control, change control, nonconformance, and deviation management, training management, and other quality management processes.

SimplerQMS integrates with Microsoft Entra ID (formerly Azure Active Directory) for user authentication and authorization, and it is hosted on Microsoft Azure cloud, ensuring secure and reliable access.

By combining M-Files and Microsoft technologies, SimplerQMS delivers a more streamlined and secure quality management experience, ensuring more efficient operations and helping ensure compliance.

SimplerQMS is a fully GAMP 5-validated quality management software designed specifically for Life Science companies. Learn how our software facilitates quality management and compliance efforts by booking a demo with our Quality Solution experts.

The following will be examined in greater detail.

• What Is M-Files?
• What Is M-Files QMS (Quality Management System)?
• What Are the Benefits of M-Files QMS?
• How SimplerQMS Uses M-Files QMS Tools?
• How SimplerQMS Uses M-Files and Microsoft Technologies?
• What Is the Role of Specialized M-Files Based QMS Software?

What Is M-Files?

M-Files is a document management software that offers a cloud-based, metadata-driven platform. The platform enables companies to manage digital data and documents in a single repository.

The M-Files document management solution is designed to automate business processes and enforce information control.

The M-Files software solution is developed and provided by its namesake company, M-Files, a global company based in Finland.

M-Files is a global leader in information management solutions. M-Files employs over 500 individuals. It collaborates with over 300 partners worldwide. M-Files serves more than 5,000 customers. Its operations extend across more than 100 countries.

M-Files is used by small, medium, and large companies worldwide, including Bahlsen in Germany, Safran in France, Crowe in the United States, and others.

What Is M-Files QMS (Quality Management System)?

M-Files QMS (Quality Management System) is a software solution designed to manage and control quality documents, procedures, records, and processes.

M-Files QMS leverages the core capabilities of M-Files’ document management system, offering features tailored for quality management.

M-Files QMS is used for managing and controlling various aspects of quality and compliance within companies, including document management, change control, training, nonconformance management, audit management, and more. The system allows streamlined document management, process automation, and workflow control.

SimplerQMS provides an Electronic Quality Management System (eQMS) built on the M-Files quality management platform. SimplerQMS enhances the robust document management and workflow capabilities of the M-Files platform to offer a comprehensive and specialized eQMS solution for Life Science companies.

What Are the Benefits of M-Files QMS?

The benefits of M-Files QMS include, but are not limited to, the following.

• Robust Document Management System
• Full Integration With Microsoft Office   
• Enterprise Level Security

Robust Document Management System

M-Files QMS serves as a centralized repository for all quality-related documents, fostering an environment of improved accessibility and control. The system helps eliminate information silos and outdated versions with a single source of truth for SOPs, procedures, forms, and records.

M-Files document management capabilities include customizable metadata for granular traceability and searchability of documents. M-files offers automated workflows to streamline review, approval, and signature processes.

Full Integration With Microsoft Office

M-Files QMS integrates seamlessly with the Microsoft Office suite, including Word, Excel, and PowerPoint.

The integration enables direct document editing within Microsoft applications. Changes in documents automatically synchronize with the central repository, eliminating burdensome download-edit-upload cycles.

Enterprise Level Security

M-Files QMS provides a robust security framework. Tamper-proof audit trails meticulously track every action, and electronic signatures further support accountability and regulatory compliance.

M-Files QMS complies and is certified to industry requirements such as ISO 9001:2015 (quality management system), ISO 27001:2022 (information security), ISO 27017:2015 (security techniques for cloud services), ISO 27018:2019 (protection of personally identifiable information), ISO 22301:2012 (business continuity management systems), SOC 2 and 3 (controls and systems security).

M-Files QMS supports achieving compliance with several requirements, including FDA 21 CFR part 11, Eudralex Vol 4 Annex 11, and HIPAA (Health Insurance Portability and Accountability Act), among others.

How SimplerQMS Uses M-Files QMS Tools?

SimplerQMS utilizes the tools provided by M-Files QMS to develop quality management modules designed for the Life Science QMS needs. SimplerQMS’s approach enables the creation of a comprehensive quality management system tailored to the unique requirements of companies in the Life Sciences industry.

Below are some of the key quality management processes where SimplerQMS utilizes M-Files QMS tools to suit the needs of Life Science companies.

• Document Control
• Change Control Management
• Training Management
• Nonconformance and Deviation Management
• CAPA Management
• Supplier Management

Document Control

SimplerQMS employs M-Files document management capabilities to control all quality-related documents. From SOPs and records to supplier information and training plans, everything resides in a single, secure location, readily available for authorized personnel.

SimplerQMS provides document control software that streamlines and automates quality-document activities, such as document review and approval process, document versioning, signing documents with electronic signatures, and more.

SimplerQMS system also integrates with Microsoft Office applications, such as Word, Excel, and PowerPoint. The integration allows documents within the system to be edited in the familiar Microsoft applications.

Change Control Management

SimplerQMS change control management module provides the foundation for effectively managing changes. Proposed changes are documented, reviewed, and approved following automated workflows.

SimplerQMS software streamlines change control management processes from initial change request creation to final approval and successful implementation.

All modifications to documents are automatically recorded within the system, complete with timestamps. These comprehensive records ensure accountability and facilitate compliance.

Training Management

SimplerQMS facilitates the management of employee training and the organization of training material. The system helps ensure employees complete training and stay up to date on essential knowledge by streamlining and automating essential tasks like training activity assignments, notifications, reminders, and training record creation.

The SimplerQMS training management capabilities enable training managers to create learning rules, assign relevant training materials, automate training assignments, track employee training progress, and more.

Nonconformance and Deviation Management

SimplerQMS software offers nonconformance management and deviation management modules.  

The nonconformance management module is designed to handle events where a product, process, or service does not meet specified requirements or standards.

Similarly, the deviation management module outlines how to control deviations in a structured and organized manner, including the event’s identification, reporting, investigation, resolution, and documentation.

All QMS modules are interlinked, allowing companies to escalate and relate nonconformance and deviations to CAPA with just a few clicks.

CAPA Management

SimplerQMS enables effective management of the CAPA lifecycle, from documenting root cause analysis to scheduling CAPA effectiveness checks.

The SimplerQMS CAPA management module simplifies the documentation and review process of quality events, facilitating continuous improvement efforts. The CAPA management module supports the development and implementation of actions aimed at preventing the recurrence of similar issues in the future.

The system also facilitates monitoring CAPA status with customizable views.

Supplier Management

SimplerQMS simplifies the management of supplier documents, contracts, qualification status, audits, and approved supplier lists (ASL).

Life Science companies use the SimplerQMS supplier management module to manage suppliers, from initial qualification and risk assessment to continuous monitoring and performance evaluation.

How SimplerQMS Uses M-Files and Microsoft Technologies?

SimplerQMS uses both M-Files and Microsoft technologies to create a comprehensive and secure Electronic Quality Management System (eQMS) tailored for the Life Sciences industry.

SimplerQMS uses the M-Files platform as its core foundation for document management and quality management processes. M-Files provides a versatile and robust document management system that supports metadata-driven document handling, version control, and process automation.

M-Files tools allow SimplerQMS to offer specialized modules for document control, change management, employee training, CAPA management, audit management, and supplier management, among others, facilitating effective quality management.

The modules include capabilities for handling controlled documents, managing change controls, planning audits, scheduling risk assessments, and more.

Broad quality management support helps Life Science companies ensure compliance with several Life Science requirements, such as ISO 9001:2015 and ICH Q10.

SimplerQMS integrates with Microsoft Entra ID (formerly Azure Active Directory) for secure user authentication and authorization.

Microsoft Entra ID provides single sign-on (SSO) capabilities and enforces strong authentication protocols like multi-factor authentication (MFA) logins, significantly reducing the risk of unauthorized access or compromised credentials.

SimplerQMS utilizes Microsoft Azure for cloud hosting, benefiting from Azure’s scalability, reliability, and security features. Azure hosting ensures that SimplerQMS offers its eQMS as a Software as a Service (SaaS), providing customers with easy access to their QMS without needing extensive IT infrastructure.

Microsoft Azure provides robust disaster recovery capabilities and supports compliance with data residency requirements, such as ISO 27001:2022, ISO 27017:2015, ISO 27018:2019, and ISO 27701:2019.

The SimplerQMS technology platform is built on established, proven technologies and complies with the industry requirements, empowering Life Science companies worldwide to confidently manage quality systems. SimplerQMS complies with Eudralex Volume 4 GMP Part I, Eudralex GMP Annex 11, FDA 21 CFR Part 11, 211, 212, and 820, and ISO 13485:2016.

Additionally, SimplerQMS is fully validated according to GAMP 5 and supports achieving compliance with Life Science-related requirements, such as ISO 13485:2016, ISO 15189:2022, 21 CFR Part 210, 211, 212 and 820, ICH Q10, and more.

Moreover, M-Files complies with ISO 27001:2022, ISO 27017:2015, ISO 27018:2014, ISO 22301:2012, ISO 9001:2015, SOC 2 and SOC 3, GDPR, SOX-404, and FIPS 140-2 Level 2.

And Microsoft Azure and Entra ID complies with ISO 27001:2022, ISO 27017:2015, ISO 27018:2014, ISO 22301:2012, ISO 9001:2015, SOC 1, SOC 2 and SOC 3, and GDPR.

What Is the Role of Specialized M-Files Based QMS Software?

Specialized M-Files-based Quality Management System (QMS) software plays an essential role in addressing the unique needs of specific industries, providing tailored solutions for effective quality management.

Regular M-Files QMS serves a broad range of applications, providing a generic framework that may require additional customization to meet industry-specific compliance requirements.

In contrast, specialized M-Files-based QMS is purpose-built, incorporating industry-specific modules and workflows from the outset. Specialization ensures a more seamless integration into the existing processes of targeted industries, addressing their regulatory requirements more precisely.

SimplerQMS is a notable example, providing a specialized Life Science QMS software by utilizing M-Files features to build quality management process support designed for pharmaceutical, medical device, biotechnological, Contract Research Organizations (CRO), Contract Development and Manufacturing Organizations (CDMO), and other related industries.

What Is the Difference Between M-Files QMS and SimplerQMS?

The difference between M-Files QMS and SimplerQMS is the level of specialization, additional services, and industry-specific focus.

M-Files QMS provides a comprehensive set of tools for document management, workflow automation, and collaboration across various industries. M-files QMS solution is adaptable to different sectors and requires additional customization to meet industry-specific needs.

On the other hand, SimplerQMS utilizes the M-Files platform to offer a specialized QMS tailored explicitly for Life Science industries.

SimplerQMS goes beyond just utilizing the M-Files tools and offers added value through a comprehensive suite of services.

SimplerQMS solution includes a personalized implementation process, ensuring a seamless integration into the existing processes of Life Science companies. Comprehensive user training is provided to teach users the necessary knowledge and skills to navigate specialized software, ensuring effective utilization.

SimplerQMS also takes charge of system validation, relieving customers from the need to allocate additional resources. SimplerQMS system is fully validated according to GAMP 5 and kept permanently validated. Moreover, ongoing support is offered to address any queries or issues, providing QMS software that supports its effective use.

SimplerQMS uses M-Files QMS and Microsoft technologies to offer a tailored quality management solution for the Life Sciences industry. SimplerQMS provides all QMS modules, system implementation, user training, full validation, and ongoing customer support.

Experience how SimplerQMS can optimize your quality management processes and support your compliance. Book a demo with our expert Quality Solution Consultants to see SimplerQMS in action.

The post M-Files QMS (Quality Management System) appeared first on SimplerQMS.

Quality system software validation is a requirement when the software is used to manage regulated processes in Life Science industries, which include pharmaceutical, biotechnology, and medical devices, among others.

This article will discuss the definition of QMS software validation, when and why electronic QMS (eQMS) validation is important, relevant requirements, validation methods, benefits, and the role of fully validated eQMS software in helping ensure quality and compliance.

Companies have been increasingly adopting eQMS (Electronic Quality Management System) solutions to streamline their quality processes and improve their compliance efforts.

SimplerQMS provides fully validated QMS software designed specifically for Life Science companies. Book a demo and talk to our quality experts to get a deeper understanding of our eQMS solution.

We will discuss the following topics in more detail:

• What Is QMS Software Validation?
• Why QMS Software Validation Is Important?
• When Electronic QMS Validation Is Necessary?
• Which Requirements Specify eQMS Validation?
• How Is the QMS Software Validated?
• What Are the Benefits of QMS Software Validation?
• What Is the Role of Fully Validated eQMS Software?

What Is QMS Software Validation?

QMS (Quality Management System) software validation is the process of systematically verifying and documenting that QMS software meets predefined requirements, operates effectively, and complies with regulatory standards. QMS software validation falls under the broader category of Computer Systems Validation (CSV), which ensures the integrity and compliance of computerized systems.

QMS software validation involves creating and executing protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

SimplerQMS provides a fully validated eQMS according to ISPE GAMP 5 and performs continuous revalidation. This means that our customers do not need to validate computer software themselves and can be confident that their eQMS is compliant and ready to use right away.

Why QMS Software Validation Is Important?

QMS software validation is important to demonstrate that the eQMS software performance is accurate and consistent. This ensures the integrity and quality of documentation and processes managed within the system.

Companies using software for managing QMS must comply with applicable FDA and ISO requirements concerning system validation.

When Electronic QMS Validation Is Necessary?

QMS software validation is necessary when it is required as per applicable regulatory requirements, specifically when computer software is used to control the quality management system.

QMS software must be validated before use and revalidated as necessary to follow any changes, according to ISO 13485:2016 Section 4.1.6 and FDA 21 CFR 820.70. Both requirements mandate these validation activities and their results to be documented.

Which Requirements Specify eQMS Validation?

QMS software validation is a requirement in several regulations, standards, and guidelines in the Life Science industry.

Below are some requirements that require eQMS validation.

FDA 21 CFR Part 11

The Food and Drug Administration (FDA) regulation 21 CFR Part 11 sets forth the criteria for electronic records, signatures, and computer systems to be trustworthy and reliable.

Regarding QMS software validation, section 21 CFR 11.10(a) specifies that systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

To learn more about this and other requirements in 21 CFR Part 11, read our dedicated article.

EU GMP Annex 11

The EU GMP Annex 11 provides the Good Manufacturing Practices (GMP) on the use of computerized systems in the Life Sciences industries in the European Union.

Section 4 provides general principles for validating computerized systems used in manufacturing pharmaceutical products. This section specifies the requirements for validation documentation, test methods, system inventory, and more.

Check out our article on Annex 11 for a deeper explanation of what this guideline entails.             

ISO 13485:2016

The international standard ISO 13485:2016 specifies the requirements for a quality management system for medical device companies.

It is established in Section 4.1.6 that the application of computer software used in the quality management system must be validated before use and after changes. The validation activities need to be equivalent to the risk associated with the use of the software.

If you are interested in knowing more about what an ISO 13458:2016 compliant QMS encompasses, read our article.

FDA 21 CFR Part 820

The FDA 21 CFR Part 820, also known as quality system regulation, sets forth the cGMP requirements for medical devices. These requirements are intended to ensure that the devices are safe and effective.

Section 21 CFR 820.70(i) states that manufacturers must validate computer or automated data processing systems when used as part of production or the quality system for its intended use.

All software changes must be validated before approval and implementation, and these validation activities and results need to be documented.

Read our article to learn more about 21 CFR Part 820 purpose and requirements.

GMP Guide Part II APIs

The GMP Guide Part II APIs is a set of international guidelines that provide guidance on GMP for the manufacturing of active pharmaceutical ingredients (APIs) in a way that meets the required quality and purity requirements.

In Section 12, it is defined that the company’s approach to validation, including the validation of computerized systems, should be documented. Systems should be periodically evaluated to verify that they are still operating in a valid manner.

How Is the QMS Software Validated?

QMS software validation is conducted through a structured process involving specific steps.

QMS software validation steps are listed below.

1. Risk Management
2. Validation Planning
3. Installation Qualification (IQ)
4. Operational Qualification (OQ)
5. Performance Qualification (PQ)
6. Validation Reporting, including the Validation Certificate

1. Risk Management

Risk management is the systematic process of identifying and addressing potential risks associated with software development, updates, and implementation.

Risk management actions should be performed to determine the impact of the software application on product quality and data integrity.

A comprehensive risk assessment and control process identifies and documents all potential risks, serving as input for developing a risk-based test plan and executing effective test cases.

The risks can be related to the software’s functionality, performance, security, and usability.

The ISPE GAMP5 guidance document provides a risk-based approach to compliant GxP computerized systems.

The GAMP5 aims to deliver a cost-effective framework of good practices to ensure that computerized systems are effective, high-quality, fit for intended use, and compliant with applicable requirements.

SimplerQMS is fully validated according to ISPE GAMP5 and undergoes revalidation for each new version or standard update.

2. Validation Planning

The validation plan is a document that outlines the system scope, development methodology, validation measures, and associated procedures.

The validation plan guides the process of ensuring that a software system meets its intended purpose and complies with relevant requirements. It serves as a roadmap for conducting validation activities and provides a framework for measuring the success of these efforts.

3. Installation Qualification (IQ)

Installation qualification is confirmed through documented evidence that the installation of all system components adheres to the established specifications.

The installation qualification verifies that items such as equipment, instruments, computer system components, measuring devices, and more are installed following the approved design, the manufacturer’s recommendations, and user requirements.

4. Operation Qualification (OQ)

Operational qualification ensures that the system or subsystem operates correctly and produces the expected results over all the anticipated operating ranges.

Appropriate operational qualification should demonstrate the suitability of computer hardware and software to perform assigned tasks.

In major software updates, OQ confirms the system’s readiness for stricter performance tests, ensuring its functionality before deployment.

5. Performance Qualification (PQ)

The performance qualification verifies that each component in a computer system works as intended and meets performance requirements. It ensures the system can handle its workload and deliver reliable results.

Performance qualification is typically conducted for major software version upgrades.

6. Validation Reporting, including the Validation Certificate

A validation report is a comprehensive document summarizing the results of a system’s validation process. It serves as a tangible record of the entire validation effort, documenting activities, findings, and, ultimately, the system’s suitability for its intended use.

Importantly, no critical issues can remain open for the system to be validated.

After a successful software validation, the validation certificate is issued. A validation certificate is a formal document stating a system has passed all validation tests and meets its intended use requirements.

We recommend watching the video below for a comprehensive overview of an eQMS validation process.

What Are the Benefits of QMS Software Validation?

The primary benefits of QMS software validation include confirming the proper functionality of the software as intended and adhering to regulatory requirements for compliance.

Below are other benefits of QMS software validation.

High Level of Security

QMS software validation helps to identify potential security risks associated with the software. Validation ensures that the software operates consistently within defined parameters, minimizing risks related to software failure or functional errors that could impact product quality or patient safety.

Comprehensive and Continuous Software Testing

Electronic quality system validation ensures that critical systems are thoroughly and continually tested. This is important because systems can change over time, and the testing process needs to be updated to reflect these changes.

Continuous testing helps to identify and fix any defects or errors before they cause larger issues in daily use.

Effective Risk Assessment

EQMS validation includes assessing potential risks associated with the software. The proactive approach to identifying and mitigating risks minimizes the probability of errors or failures that could impact product quality and safety.

Enhanced Reliability

A validated QMS software is generally more reliable because it has undergone rigorous testing. This ensures that all functions work as intended in different scenarios and conditions.

Data Integrity

Validation processes include steps to ensure that data is accurately recorded and maintained, thereby improving the overall integrity of the data.

The benefits of QMS software validation are numerous and far-reaching. Maintaining a validated QMS software is essential for any Life Science company wanting to achieve these benefits.

What Is the Role of Fully Validated eQMS Software?

The main role of fully validated eQMS software is to help ensure regulatory compliance and quality assurance across all organizational processes.

Validated quality management software is a centralized system streamlining quality processes and storing relevant documentation. It helps ensure that the company complies with internal and external requirements.

Companies have three options for QMS software validation, as listed below.

• Do it themselves.
• Outsource to a service provider.
• Use fully validated QMS software like SimplerQMS.

The best option for each company will depend on its specific needs and requirements.

However, validating QMS software yourself can be challenging, as it involves a manual process that can be time-consuming and costly. Outsourcing to specialized service providers can also be expensive.

On the other hand, fully validated QMS software can provide everything a company needs and give the peace of mind of using a validated system that saves time, costs, and work in validation and revalidation tasks.

SimplerQMS provides a fully validated eQMS according to ISPE GAMP5. We maintain our software in a validated state by updating it whenever new versions or changes are introduced. SimplerQMS handles all validation tasks for our customers.

In addition to being ISPE GAMP5 validated, our platform supports compliance with several Life Science requirements such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, 212, and 820, EU GMP Part I, EU GMP Annex 11, and more. SimplerQMS software helps companies achieve regulatory compliance by providing comprehensive QMS process support.

Our solution supports QMS processes, including document management, change control, employee training, deviation management, CAPA management, customer complaint management, audit management, supplier management, and more.

If you are unsure about the benefits of implementing an eQMS, we recommend using our eQMS Business Case template. This tool will help you assess the value of eQMS for your company and present your findings to management.

The template provides a structured approach to evaluating aspects such as cost savings, improved efficiency, and enhanced regulatory compliance.

Final Thoughts

QMS software validation is essential to ensure that the quality management system software works as intended and to comply with regulatory requirements for companies in regulated industries.

QMS software validation can be done by the company itself or by an outsourced service provider. However, both of these options can be labor-intensive and expensive.

A better alternative is to implement already validated software, which can save you time and costs and give you peace of mind knowing that the software is fit for purpose.

SimplerQMS provides a fully validated eQMS solution according to ISPE GAMP 5.

The software is kept in a validated state continuously, and SimplerQMS handles all validation and revalidation tasks on your behalf. This means you do not have to worry about anything and can focus on using the software to improve your quality management.

You can book a free demo with one of our quality experts to learn more about how our QMS software can help you streamline quality process management in your company.

The post QMS Software Validation: Everything You Need to Know appeared first on SimplerQMS.

Management reviews allow Life Science companies to identify and address areas for improvement and ensure their QMS remains suitable, adequate, and effective for the company’s goals and objectives.

This article discusses the aspects of quality management review, including its definition, purpose, frequency, requirements, and contents. It also explains the role of QMS software in management reviews.

Life Science companies understand the complexity of quality management processes. Hence, companies are increasingly adopting QMS Software solutions to manage their quality processes, including providing a seamless approach to planning and capturing the details of their management reviews.

SimplerQMS provides fully validated eQMS software designed specifically for Life Science companies. You can book a free demo with one of our specialists to see how it can enhance your quality management processes.

This article will discuss the following topics:

• What Is a Quality Management Review (QMR)?
• What Is the Purpose of a Quality Management Review?
• Why Is Quality Management Review Needed?
• How Often Should a Quality System Undergo Management Review?
• Which Requirements Specify Quality Management Reviews?
• What Should Be Included in Quality Management Review?
• What Is the Role of QMS Software in Quality Management Reviews?

What Is a Quality Management Review (QMR)?

A Quality Management Review (QMR) is a formal process for assessing the effectiveness, suitability, and adequacy of the quality management system (QMS).

Quality management reviews an opportunity for top management to review the company’s QMS performance against its Quality Key Performance Indicators (KPIs), identify areas for improvement, and make decisions about allocating resources.

Below are the definitions of quality management review as specified in some of the most common standards, guidelines, and regulations.

• ISO 9001:2015: A QMR is a process conducted to determine a system’s suitability, adequacy, or effectiveness to achieve established objectives.
• ICH Q10: Quality management review is a formal process for periodically reviewing the pharmaceutical quality system.
• FDA 21 CFR Part 820: Management review is the review of the suitability and effectiveness of the quality system at defined intervals.
• ISO 13485:2016: The QMR is the top management review of the quality system at documented planned intervals to ensure its continuing suitability, adequacy, and effectiveness.

What Is the Purpose of a Quality Management Review?

The main purpose of a quality management review is to identify improvement opportunities and ensure the company’s quality management system remains effective and aligned with its strategic direction.

The QMR addresses the possible need for changes to quality policy, objectives, and other quality management system elements.

Why Is Quality Management Review Needed?

Quality management reviews are essential for Life Science companies because they are required for regulatory compliance, as per ISO 9001:2015, 21 CFR Part 820, ICH Q10, and other requirements.

Life science companies must show proof that management reviews have been executed to demonstrate their commitment to the quality, safety, and efficacy of their products.

The QMRs also help companies address potential quality issues, which leads to developing and implementing solutions that help improve quality and safety and reduce costs.

How Often Should a Quality System Undergo Management Review?

Quality management systems should undergo periodic management reviews at least once a year to assess their effectiveness and ensure they are still meeting the company’s needs.

It is important to note that the requirements for quality management reviews do not specify a specific frequency. Instead, companies are given the flexibility to determine the frequency that is best for them based on their specific needs and circumstances.

Which Requirements Specify Quality Management Reviews?

Several requirements specify Life Science companies perform regular quality management reviews, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, and other requirements.

Below are Life Science requirements that specify the criteria related to quality management reviews in greater detail.

ISO 9001:2015

The international standard ISO 9001:2015 specifies the requirements for quality management systems. This is a versatile standard, not limited to a single industry, and can also be applied to the Life Science sector.

Section 9.3 requires top management to review the QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the company’s strategic direction.

The organization must keep documented information as evidence of the results of management reviews.

ISO 13485:2016

ISO 13485:2016 is an international standard that defines the requirements for a quality management system (QMS) specific to the medical device industry.

The standard specifies in Section 5.6 that companies must document procedures for management reviews. Top management must regularly review the quality management system to ensure it is still suitable, adequate, and effective.

The review should assess opportunities for improvement and the need for changes to ensure an ISO 13485:2016 compliant quality management system.

All records of management reviews must be kept.

FDA 21 CFR Part 820

The Food and Drug Administration (FDA) 21 CFR Part 820, also known as the Quality System Regulation (QSR), outlines the Current Good Manufacturing Practice (cGMP) requirements for all finished medical devices intended for human use.

Section 21 CFR 820.20(c) specifies that management must review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.

The goal is to ensure the quality system satisfies the FDA requirements and the manufacturer’s established quality policy and objectives.

Companies in compliance with the 21 CFR Part 820 quality system regulation shall document all dates and results of quality system reviews.

ICH Q10

The international guideline ICH Q10 describes a model for an effective quality management system for the pharmaceutical industry.

Section 2.6 establishes that top management should be responsible for controlling the ICH Q10 pharmaceutical quality system through quality management review to ensure that it remains suitable and effective.

Management should evaluate the findings of periodic management reviews of process performance, product quality, and the pharmaceutical quality system.

What Should Be Included in Quality Management Review?

The quality management review should include supporting documents, review inputs, and review outputs.

Supporting Documents

Supporting documents in the context of quality management reviews are any documents, records, data, or other materials that provide additional information or context to the review process.

These documents help to support findings, identify areas for improvement, and track progress over time.

Below are examples of supporting documents.

Quality Manual

The quality manual is a document that describes the company’s quality management system, including its purpose, scope, and key processes. It also describes how the QMS complies with the requirements of a specified quality standard, such as ISO 9001:2015 or ISO 13485:2016.

Overall, the quality manual provides a framework for assessing the effectiveness, suitability, and adequacy of the QMS.

Quality Policies

The policies are statements that define the company’s commitment to quality. It outlines the values and principles regarding quality and guides how to achieve quality objectives.

Meeting Minutes of Previous QMRs

Quality management review meeting minutes are documents of the decisions and actions taken during previous QMRs. They provide a historical record of QMR outcomes and help to track progress over time.

Standard Operating Procedures (SOP)

The standard operating procedure (SOP) is a document that provides high-level guidelines for a process. Following SOPs ensures that QMS processes are performed consistently and effectively.

Quality Records

The quality records provide objective evidence of the QMS in operation, documenting activities performed, and the results achieved. Records are important for QMRs because they provide proof that the QMS is meeting its requirements.

Work Instructions

The work instruction is a detailed step-by-step guidance document that provides instructions on how to perform a specific task. They provide evidence of how the QMS is implemented and controlled at the individual task level.

What Are the Quality Management Review Inputs?

Management review inputs are the various sources of information used to assess the effectiveness of the quality management system.

The following are examples of management review inputs based on ISO 9001:2015, ISO 13485:2016, and ICH Q10.

Changes That Could Affect the Quality Management System

Changes that could impact the QMS include changes to products, processes, and regulatory or customer requirements.

Identifying and assessing changes that could impact the QMS is important for ensuring that it remains effective and aligned with the company’s quality goals.

Customer Satisfaction and Feedback

Customer satisfaction and feedback documents are statements from customers, including complaints, suggestions, and compliments. They are essential to provide insights into how customers perceive the company’s products and services and how the QMS can be improved to meet customer needs.

Process Performance and Conformity of Products

Process performance and conformity of products are measurements of how well the company’s processes are performing and whether products and services are meeting requirements.

They are essential for ensuring that the QMS is meeting its objectives and that products and services meet regulatory and customer requirements.

Nonconformances and CAPAs

Nonconformances are events of a product, service, or process that do not comply with the established requirements. They are described in the nonconformance reports.

Corrective and preventive actions (CAPAs) are actions taken to address issues, such as nonconformances, and avoid similar ones from occurring.

Reviewing nonconformances and CAPA in quality management reviews is an essential part of continuous improvement and maintaining an effective QMS.

Monitoring and Measurement of Quality KPIs

Quality Key Performance Indicators (KPIs) are specific and relevant metrics that provide evidence of the performance of the QMS and progress toward a specific goal.

By tracking quality KPIs over time, Life Science companies can identify trends, areas for improvement, and the effectiveness of the quality system.

Effectiveness of Actions Taken To Address Risks and Opportunities

Tracking the effectiveness of actions taken to address risks and opportunities helps to ensure that the QMS is proactive and effective in managing risks and seizing opportunities.

Opportunities for Improvement

The opportunities for improvement are areas where the QMS can be improved to enhance its effectiveness and efficiency. The QMR should identify opportunities for improvement, such as streamlining processes, reducing waste, or improving customer service.

Audits Findings

The audit findings are the results of internal and external audits of the QMS. They provide independent and objective feedback on the effectiveness of the QMS.

Audit findings should be reviewed and addressed to ensure that the QMS meets its requirements and that any quality issues are corrected.

Applicable New or Revised Regulatory Requirements

Any new or revised regulations that impact the QMS should be reviewed to ensure that the QMS is compliant and that any necessary changes are made.

What Are the Quality Management Review Outputs?

Management review outputs are the results of the management review process. They are the decisions and actions that are taken to improve the effectiveness of the company’s quality management system.

The following are examples of management review outputs based on ISO 9001:2015, ISO 13485:2016, and ICH Q10.

Revisions to Quality Policy and Quality Objectives

Revisions to quality policies and objectives are updates to the company’s policies and objectives to ensure they remain aligned with its strategic goals and requirements.

Improvement of the Quality Management System

Improvement of the QMS includes all actions taken to enhance the effectiveness of the quality system in meeting its objectives and is continuously improving.

Improvement of Product Related to Customer Requirements

The improvement of products related to customers is the actions taken to ensure products meet or exceed customer expectations.

Allocation or Reallocation of Resources

Allocation or reallocation of resources in quality management refers to the decision-making process of determining how to assign or reassign financial, human, and other resources to support the QMS and its processes in being effective.

Personnel Training Needs

Personnel training needs are the gaps between the knowledge, skills, and abilities that personnel currently have and those that they need to perform their jobs effectively.

The QMR should identify training needs and help develop training programs to address the knowledge and skills gaps of personnel involved in the QMS.

Timely and Effective Communication of the Results

Communication of the results is the process of sharing the outcomes of the quality management review with relevant personnel in a timely and comprehensive way. This is important to ensure that all employees are aware of the results of the review and that any necessary actions are taken.

To improve the efficiency and effectiveness of quality management reviews, many Life Science companies are implementing QMS software solutions. Such solutions facilitate the planning, execution, and documentation of the quality management review processes, securing more consistent and reliable outcomes.

What Is the Role of QMS Software in Quality Management Reviews?

The role of QMS software in quality management review is to streamline the entire management review process, enabling companies to consistently assess and improve the quality management system effectively.

The QMS software provides a centralized platform to facilitate the systematic planning, execution, and documentation of management reviews, allowing real-time access to data for informed decision-making.

The software helps track and monitor key review inputs, such as audit findings, nonconformances and CAPAs, customer feedback, and process performance.

Automated reminders and notifications and easy access to quality KPI data improve visibility and accountability, making the review process more transparent and efficient.

SimplerQMS is a fully validated, according to GAMP 5, eQMS software solution for Life Sciences that simplifies quality management reviews.

The software provides several features that can be used to support management reviews, including creating and managing archives and projects related to documents, streamlining data collection, and generating quality KPI reports.

SimplerQMS helps Life Sciences companies comply with a variety of requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, EU GMP, and more.

The system provides comprehensive support for QMS processes, such as document management, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.

To assess how an investment in an eQMS solution could benefit your company, download our eQMS Business Case template today.

With the template, you can learn more about the specific benefits that SimplerQMS can offer your business, such as potential efficiency gains, cost savings, and compliance improvements. By clearly and concisely presenting this information to management, you can build a strong case for implementing an eQMS.

Final Thoughts

A Quality Management Review (QMR) is a formal process for top management to assess the quality management system’s (QMS) effectiveness, suitability, and adequacy. The main purpose of QMR is to identify opportunities for improvement and ensure continuous suitability and alignment with the company’s strategic goals.

QMS software collects quality data from production processes, inspections, audits, customer feedback, and more, providing real-time access to information and improving evidence-based decision-making.

SimplerQMS is a fully validated (GAMP 5) eQMS software solution for Life Sciences that simplifies the management review process by providing a centralized platform for planning, execution, and documentation of management reviews.

Improve your quality management review process with SimplerQMS. Schedule a demo with our quality experts to learn how our software can streamline your QMS management.

The post Quality Management Review (QMR) in Life Science Industries appeared first on SimplerQMS.

Quality KPIs are crucial in the pharmaceutical industry, where products and services directly impact human health and well-being. By tracking quality KPIs, companies can measure their performance and make informed decisions on their products, services, and processes’ effectiveness and compliance.

This article defines quality KPIs in the pharmaceutical manufacturing industry. It also explains their importance, and relevant requirements, exemplifies metrics to track, and the role of eQMS software in monitoring these KPIs.

Pharmaceutical companies are increasingly recognizing the importance of quality assurance and turning to QMS software solutions to streamline processes and improve the accuracy of quality KPI tracking.

SimplerQMS offers fully validated (GAMP 5) eQMS software designed specifically for Life Science companies that also includes quality KPI tracking capabilities. You can book a free demo to see SimplerQMS in action and better understand the capabilities of our solution.

This article covers the following topics:

• What Are Quality KPIs in the Pharmaceutical Industry?
• Why Are Quality KPIs and Metrics Important in the Pharmaceutical Industry?
• Which Requirements Mention Quality KPI Measurement?
• What Are the Key Quality KPIs and Metrics That Pharmaceutical Companies Should Track?
• What Is the Role of Pharmaceutical Quality KPI Monitoring Software?

What Are Quality KPIs in the Pharmaceutical Industry?

Like in many other industries, quality KPIs (Key Performance Indicators) in the pharmaceutical industry are quantifiable metrics that track and assess the performance of a company’s processes, services, or products.

The KPIs should be specific, measurable, achievable, relevant, and time-bound. They should also be aligned with the company’s overall quality strategy and objectives.

Both quality metrics and KPIs are measurements that track performance, but they serve different functions.

The difference between quality metrics and quality KPIs in Life Science is that metrics are detailed measurements for monitoring processes used internally for operational improvements, such as defect rates. However, quality KPIs are a strategic subset of metrics influencing broader business decisions and communicating performance to stakeholders, such as customer satisfaction.

Why Are Quality KPIs and Metrics Important in the Pharmaceutical Industry?

Quality KPIs and metrics are essential in the pharmaceutical industry, given their direct impact on human health and well-being.

Pharmaceutical companies have been tracking and monitoring quality KPIs and metrics for a long time, helping ensure the quality of their products, driving continuous improvement efforts, and helping ensure compliance with regulatory requirements.

Tracking quality KPIs and metrics, such as process performance, audit findings, customer complaints, and others, helps companies to ensure the effectiveness of the quality management system.

Which Requirements Mention Quality KPI Measurement?

Several requirements applicable to pharmaceutical companies, such as ISO 9001:2015, ICH Q10, and the FDA Quality Metrics Reporting program, among others, mention quality KPI measurement.

Below are a few examples of requirements that specify quality KPI.

ISO 9001:2015

The international standard for quality, ISO 9001:2015, is a standard that provides a set of requirements for companies to implement a quality management system (QMS).

ISO 9001:2015 mentions in Section 4.4.1 that companies must monitor the processes for the quality management system using KPIs that help ensure the effective operation and control of these processes.

ICH Q10

The ICH Q10 is a guideline for the pharmaceutical quality system.

Section 4.1 specifies management should have a formal process for reviewing the pharmaceutical quality system periodically.

The review should include the assessment of KPIs to monitor the effectiveness of processes within the pharmaceutical quality system, such as:

• Complaint
• Deviation
• CAPA
• Change management processes
• Supplier
• Risk assessment
• Audits
• Regulatory inspections

The ICH Q10 provides a comprehensive model for an effective pharmaceutical quality system. If you want to know more about this requirement, please read our dedicated article on ICH Q10 pharmaceutical quality system guidelines.

FDA Quality Metrics Reporting Program

The FDA Quality Metrics Reporting program is a voluntary data-sharing program for companies to help the FDA identify and mitigate product quality risks.

The FDA proposes developing and implementing a Quality Metrics Reporting Program to support its quality surveillance activities. This program would require companies to submit quality metrics data to the FDA.

The KPI reporting program is intended to help the FDA identify and address potential quality problems before they impact the safety and efficacy of pharmaceutical products.

What Are the Key Quality KPIs and Metrics That Pharmaceutical Companies Should Track?

The key quality KPIs and metrics that pharmaceutical companies can track vary depending on the product, processes involved, and quality goals.

The FDA Quality Metrics Reporting Program is working toward establishing a public docket where they propose some KPIs pharmaceutical companies should track.

Below are examples of KPIs for different pharmaceutical practice areas according to the FDA Quality Metrics Reporting Program.

Manufacturing Process Performance

Manufacturing process performance refers to the evaluation of how effectively and efficiently a manufacturing process operates.

The following are examples of manufacturing process performance KPIs and manufacturing metrics that can measure the effectiveness and efficiency of drug manufacturing operations.

Process Capability/Performance Indices (CPK/PPK)

Process capability and performance indices are measures of how well a process is performing relative to its specification limits.

Process capability and performance indices are calculated using statistical methods to determine how well a manufacturing process is meeting its requirements.

Lot Acceptance Rate (LAR)

The lot acceptance rate is the proportion of lots that were accepted in a given period.

It is calculated by dividing the number of lots that were accepted by the total number of lots that were produced.

Some examples of inputs that can be used to calculate LAR include:

• Lots completed
• Lots dispositioned
• Lots attempted
• Lots rejected
• Lots released
• Lots approved
• Abandoned lots
• Parallel/backup lots

Right-First-Time Rate (RFT)

The right-first-time rate is a measure of the proportion of lots manufactured without the occurrence of a deviation or nonconformance.

The RFT is calculated by dividing the number of products or processes that are completed correctly on the first attempt by the total number of products or processes completed.

Examples of inputs that can be used to calculate a right-first-time rate include:

• Number of deviations
• Lots dispositioned
• Lots attempted
• Number of nonconformances
• Lots approved in the first pass

Lot Release Cycle Time

Lot release cycle time is a measure of the amount of time it takes for the lot disposition process.

It is calculated by measuring the time from the completion of the manufacturing process to the release of the lot for shipment. For instance, it can be calculated in hours, days, or weeks.

Pharmaceutical Quality System Effectiveness

Pharmaceutical quality system effectiveness is the degree to which a pharmaceutical company’s QMS can achieve its intended objectives.

It is a measure of how well the pharmaceutical quality system helps ensure products are safe, effective, and of high and uniform quality.

The following are examples of KPIs and metrics that can be used to assess the effectiveness of a pharmaceutical company’s quality management system in consistently producing and controlling the quality of pharmaceutical products while meeting applicable requirements.

CAPA Effectiveness

CAPA effectiveness is the measurement of CAPA plans that have been implemented and deemed successful.

CAPA effectiveness is calculated by monitoring the CAPA plans that have been closed as effective in relation to the total number of CAPA plans that have been initiated.

Repeat Deviation Rate

The repeat deviation rate is a metric of the deviations that occur multiple times. In other words, it tells you how often a specific deviation occurs. A high repeat deviation rate KPI indicates that a particular deviation is occurring frequently and that corrective action needs to be taken.

Change Control Effectiveness

Change control effectiveness is the measure of how well a company manages changes to its GMP facilities, systems, equipment, or processes in a timely and effective manner.

Examples of inputs that can be used to calculate this metric include:

• On-time closure of the change
• Total number of late effectiveness checks
• Total number of changes initiated
• Number of changes that are initiated reactively versus proactively
• Total number of changes deemed effective

Overall Equipment Effectiveness

Overall, manufacturing equipment effectiveness is the measure of how well a machine or production line is performing relative to its full potential.

It is calculated taking into account three factors: availability, performance, and quality.

Unplanned Maintenance

Unplanned maintenance is the tracking of maintenance that is not planned or scheduled in advance. It is often caused by unexpected equipment failures.

Some inputs that can be used to calculate this metric include total maintenance hours and planned maintenance hours.

Laboratory Performance

Laboratory performance is the ability of a laboratory to produce accurate and reliable test results.

The examples below are laboratory performance KPIs and metrics that can be used to measure the efficiency and accuracy of a pharmaceutical company’s laboratory.

Adherence To Lead Time

The adherence to lead time is the proportion of laboratory tests that are completed on time, according to schedule requirements.

This metric can be calculated by tracking the number of days between the test start date and completion date for quality control.

Right-First-Time Rate

Right-first-time is the measurement of the proportion of laboratory tests that are conducted without the occurrence of a deviation.

The right-first-time rate can be calculated by tracking the number of invalid assays due to human errors or cGMP documentation errors during a review.

Invalidated/Overturned Out-Of-Specification Rate (IOOSR)

The invalidated or overturned out-of-specification rate is the measure of the laboratory’s ability to perform tests accurately.

Some inputs that can be used to calculate this metric are the total number of tests conducted and the out-of-specification results.

Calibration Timeliness

Calibration timeliness is the measurement of the laboratory’s adherence to inspecting, calibrating, and testing equipment for its intended purposes. This metric can be measured by tracking calibration criteria and schedules.

Supply Chain Robustness

Supply chain robustness is the ability of a supply chain to withstand changes and continue to operate effectively. It is a measure of the supply chain’s resilience and adaptability.

The following are examples of KPIs and metrics that can be used to assess the supply chain’s ability to meet the company’s needs for raw materials, components, and finished products on time and in full.

On-Time In-Full (OTIF)

On-time in full is a supply chain metric that measures the percentage of orders that are delivered to the customer containing the correct quantity and according to the schedule.

Examples of inputs that can be used to calculate this quality KPI include:

• Number of orders shipped
• Number of past-due orders
• Number of orders shipped within tolerance

Fill Rate

The fill rate is the quantification of how many orders were sent out compared to the total amount of orders during a specific time.

Examples of inputs that can be used to calculate the fill rate include:

• Total number of orders shipped
• Number of orders placed
• Number of orders received

Disposition On-Time

Disposition on time is a measure of how well a company can release batches of products on time.

Examples of inputs that can be used to calculate this metric include the total number of lots dispositioned and the total number of lots dispositioned on time.

Days of Inventory On-Hand

Days of inventory on hand is the measure of how long it takes a company to sell its inventory. It is the number of days that inventory remains in stock.

What Is the Role of Pharmaceutical Quality KPI Monitoring Software?

Pharmaceutical quality KPI monitoring software assists pharmaceutical companies in automating the tracking and reporting of quality metrics in real-time, as well as providing a centralized platform for gathering data on various quality metrics and pharmaceutical KPIs.

Modern QMS software solutions offer quality KPI monitoring capabilities.

SimplerQMS is a fully validated (GAMP 5) eQMS software solution for Life Sciences. It also simplifies access to quality KPI data, allowing for timely decision-making and proactive quality management.

SimplerQMS provides periodic KPI reports that could be tailored according to the company’s needs.

SimplerQMS supports compliance with several Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, EU GMP, and more. SimplerQMS solution provides comprehensive support for QMS processes, helping Life Science companies to achieve and maintain compliance.

QMS processes supported include document management, change management, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.

To assess the benefits of implementing an eQMS for your company, download our eQMS Business Case template.

The template will help you calculate the potential efficiency gains, cost savings, and compliance improvements. By presenting this information to management clearly and concisely, you can build a strong case for implementing an eQMS.

Final Thoughts

Quality KPIs are specific metrics that measure the performance of a company’s process, service, or product. KPIs are used to track progress toward quality goals, thus helping companies to identify areas for improvement and ensure compliance with regulatory requirements.

Nowadays, many eQMS solutions also offer quality KPI monitoring capabilities. The software automates the tracking of quality metrics and provides a centralized platform for gathering data on various quality parameters.

SimplerQMS is a fully validated (GAMP 5) eQMS software solution for Life Sciences. Our system includes dashboards that display users’ tasks and assignments as soon as they log in and include graphics for easy data visualization. Furthermore, we provide periodic KPI reports that can be tailored according to the company’s needs.

Discover how SimplerQMS can help you improve your quality KPI monitoring. To learn more about how our software can streamline your QMS management, schedule a demo with our quality experts.

The post Quality KPIs in the Pharmaceutical Industry appeared first on SimplerQMS.

Quality KPIs are essential in the Life Science industry, where products and services can have a direct impact on human health and well-being. Tracking quality KPIs allows companies to measure their performance, uphold rigorous requirements, and ensure that their products, services, and processes are safe, effective, and reliable.

This article discusses quality key performance indicators, the most important quality metrics to track, how to set and measure KPIs, and the benefits of quality KPI monitoring. It also discusses the role of quality KPI monitoring software.

Recognizing the critical role of quality assurance, Life Science companies are now moving towards adopting QMS software solutions, seeking to streamline their processes and improve the precision in monitoring quality KPIs.

SimplerQMS offers comprehensive eQMS software equipped with quality KPI tracking capabilities designed for the unique needs of Life Science companies. You can book a free demo to learn how our eQMS solution can help your company achieve its quality goals.

This article covers the following topics.

• What Are Quality KPIs (Key Performance Indicators)?
• What Are the Most Important Quality KPIs and Metrics to Track?
• How to Set Quality KPIs?
• How to Measure Quality KPIs?
• What Are the Main Benefits of Quality KPI Monitoring?
• What Is the Role of Quality KPI Software?

What Are Quality KPIs (Key Performance Indicators)?

Quality KPIs (Key Performance Indicators) are specific, measurable, and relevant metrics that track and evaluate the quality of work, processes, services, or products in a company.

The specific quality KPIs for a company to monitor will vary depending on its industry, compliance requirements, and specific goals.

It is important to regularly review and analyze these KPIs to make informed decisions and continuously improve the quality management of products, services, and processes.

What Is the Difference Between Quality KPIs and Quality Metrics?

Quality KPIs and quality metrics both measure performance, but they serve different functions.

Quality metrics are measurements used for monitoring and controlling specific processes, such as defect rates or inspection counts. Metrics are mostly used internally for operational improvements.

In contrast, quality KPIs are a focused selection of metrics that directly reflect the organization’s strategic goals. KPIs are critical indicators, for example, customer satisfaction or return rates, that influence business decisions and are used to communicate performance to stakeholders and top management.

What Are the Most Important Quality KPIs and Metrics to Track?

The most important quality KPIs and metrics to track are those that offer clear insights into the aspects of performance that matter most to the specific quality goals of the company.

The choice of quality KPIs and metrics to monitor can vary significantly based on the stage and size of a company.

Below are some examples of KPIs and metrics that Life Sciences companies could track to measure quality and performance across five key focus areas.

• Risk
• Issue response
• Cost of poor quality
• Process efficiency
• Resource maturity

Risk

Risk-related quality KPIs and metrics help measure the effectiveness of the risk management process in mitigating potential risks to product quality and compliance.

Overdue Training

Overdue training is any training that an employee is required to do but has not yet completed, exceeding the deadline.

Tracking overdue training is essential to help ensure that employees are trained on time and have the skills and knowledge they need to perform their jobs safely and effectively.

Audit Findings

Audit findings are factual statements that document divergences from requirements or procedures identified during an audit.

Audit findings identify compliance issues, operational inefficiencies, and risks. They can lead to corrective and preventive actions that improve process performance and compliance.

Compliance Issues

Compliance issues are any violations of applicable requirements. These issues can be caused by a variety of factors, such as human error, poor communication, lack of awareness of requirements, insufficient resources, unclear or outdated procedures, or lack of training.

Measuring compliance issues helps to identify and address compliance gaps before they lead to fines, penalties, or other legal consequences. It also helps companies to prevent similar compliance issues from happening in the future.

Overdue Risk Assessments

Risk assessment is a systematic process to identify, evaluate, and mitigate the potential risks to patient safety and product efficacy at all stages of development, manufacturing, and distribution. Overdue risk assessments are risk assessments that have not been completed on time or reviewed in connection with change requests, nonconformance, deviation, audit findings, customer complaints, CAPA, etc.

This can include risk assessments for new products or processes, as well as periodic risk assessments for existing products and processes.

Tracking and monitoring overdue risk assessments helps ensure that potential risks are evaluated and mitigated promptly, maintaining compliance and safeguarding product quality and safety.

High Number of Changes

A high number of changes is any situation where a product or process is undergoing a significant number of changes in a short period. This can increase the risk of errors and quality problems.

Measuring the number of changes helps companies identify areas where there is a high risk of errors and quality problems to minimize the impact of changes on product quality and customer satisfaction.

Overdue CAPA

Corrective and preventive action (CAPA) is a systematic approach to identifying, investigating, and solving quality issues and preventing them from happening again. Overdue CAPAs are CAPAs that have not been completed on time.

By tracking and monitoring overdue CAPAs, companies can improve their CAPA process and reduce the risk of regulatory compliance issues.

Issue Response

Issue response KPIs and metrics are quantitative measures used to assess the effectiveness of a company’s process for addressing and resolving issues.

Customer Satisfaction Scores

Customer satisfaction scores are a measure of how satisfied customers are with a product, service, or company. This data can be collected through surveys, customer interviews, or other feedback mechanisms.

Tracking customer satisfaction scores is essential since customer satisfaction is one of the key drivers of business success.

Churn Rate

The churn rate is the percentage of customers who stop using a product or service within a given period. The churn rate is calculated by dividing the number of customers who churned by the total number of customers at the beginning of the period.

Measuring churn rate helps to identify and address areas where companies are losing customers. By understanding why customers are churning, companies can take steps to improve their products or services.

Customer Complaints

Customer complaints are any expressions of dissatisfaction that customers make about a product, service, or company. Customer complaints can be received through a variety of channels, such as phone calls, emails, social media, and customer surveys.

Tracking customer complaints is essential to identify and address issues that are impacting customers.

Overdue Issues

Overdue issues are any issues that have not been resolved within the agreed-upon timeframe. Overdue issues can include customer complaints, technical support tickets, and product warranty claims.

Monitoring overdue issues helps companies ensure that issues are being resolved promptly and efficiently.

Time To Solve Issues

Time to solve issues is the average amount of time it takes to resolve an issue. It is calculated by dividing the total time spent resolving issues by the number of events resolved.

Tracking the time to solve issues helps companies to identify and address areas where issues are taking too long to resolve. By reducing the average time, companies can improve responsiveness and effectiveness.

Time To Respond to Customers

Time to respond to customers is the average amount of time it takes to respond to a customer inquiry or request.

Measuring the time to respond to customers ensures that customers are being responded to promptly and efficiently. Long response times can lead to customer frustration and dissatisfaction.

Corrective Actions Effectiveness

Corrective actions are steps taken to correct the root cause of an issue. Corrective action effectiveness is the degree to which corrective actions are successful in solving issues.

By tracking corrective action effectiveness, companies can identify and address areas where their corrective actions are not effective.

Cost of Poor Quality

KPIs measuring the cost of poor quality track the financial and non-financial costs from defects and errors associated with failing to meet requirements, such as rework, scrap, warranty claims, and lost customers.

Defect Rates

The defect rate is the percentage of products or services that do not meet the applicable requirements.

Tracking defect rates helps companies identify and address areas where quality issues are occurring.

Rework Needed

Rework needed is the amount of work that needs to be done to correct defective products or services. Rework can include fixing defects, replacing defective parts, or re-performing services.

Rework can be a significant expense, both in terms of direct costs, such as labor and materials, and indirect costs, like lost productivity and delayed deliveries.

By tracking the rework needed, companies can identify areas where they need to improve their quality processes to reduce costs.

Nonconformances

Nonconformances are any events where a product, service, or process does not meet the applicable requirement.

Measuring nonconformances is important to help prevent quality issues and ensure that products and services are meeting customer and regulatory requirements.

Right-First-Time

Right-first-time is a measure of how often products or services are completed correctly and without defects the first time around.

Tracking right-first-time is essential since it is a key indicator of the effectiveness of a company’s processes.

High rates indicate that the company is producing uniform and high-quality products and services. Low rates indicate that the company needs to improve its processes to reduce the number of defects and rework.

Wasted Product and Time

Wasted product and time are the costs associated with defects and rework. This can include the cost of the materials used to produce defective products, the cost of labor to rework defects, and the cost of lost productivity.

Measuring wasted product and time helps companies to quantify the impact of quality issues. This information can be used to make informed decisions about investing in quality improvement initiatives.

Process Efficiency

Process efficiency KPIs measure the degree to which a process uses resources effectively by converting inputs, such as time, money, and materials, into valuable outputs to achieve its desired outcome.

Overdue Activities

Overdue activities are any tasks that are not completed on time. This can include audit responses, equipment calibration tasks, maintenance tasks, training assignments, and many others.

By tracking overdue activities, companies can identify and address bottlenecks and other inefficiencies in their processes.

Response Time To Audit Findings

Response time to audit findings is the amount of time it takes to investigate and address audit findings.

Tracking response time to audit findings is essential, as it measures the effectiveness and responsiveness in resolving compliance issues. For example, a delayed response to audit findings could result in additional nonconformances.

Completed Training

Completed training is the percentage of employees who have completed the required training programs on time.

Tracking completed training helps companies ensure that their employees are up to date with the latest procedures.

Resource Maturity

Resource maturity KPIs and metrics measure the development and competency levels of a company’s workforce and systems, including personnel training adequacy, equipment, and technology.

Training Scores

Training scores are the results that employees achieve on training assessments, such as quizzes.

By tracking training scores, companies identify how well the training was understood, areas where their training plans need to be improved, and employees who may need additional training support.

Read & Understood Assignments

Read and understood assignments are the number of assignments that employees have read and understood, as evidenced by their signature upon completion.

Measuring read and understood assignments helps to ensure compliance, safety, and quality processes within the company, as it helps to ensure that employees are aware of and understand their responsibilities and the procedures they must follow.

Number of Change Requests

Number of change requests is the number of requests for changes to products, services, or processes.

The number of change requests can be used to measure the level of continuous improvement initiatives, identify potential areas of inefficiency, and ensure that the organization can adapt to new information, technology, and market demands to maintain competitiveness and compliance.

Improvement Acceptance Ratio

The improvement acceptance ratio is the percentage of improvement suggestions that are accepted and implemented by the company.

Measuring the improvement acceptance ratio helps measure how supportive a company is of innovation and continuous improvement. A high improvement acceptance ratio indicates that the company is open to new ideas and is committed to improving its products, services, and processes.

How to Set Quality KPIs?

The first step in setting quality KPIs is to identify the company’s quality goals. Afterward, companies can start to identify specific KPIs that will measure progress toward those goals.

Using the SMART criteria is a widely recognized approach to setting meaningful and actionable KPIs.

SMART stands for Specific, Measurable, Achievable, Relevant, and Time-bound. Below is a more detailed explanation of each of these criteria:

• Specific: The KPI should be specific and clearly defined.
• Measurable: KPIs should be quantifiable, allowing for objective assessment of progress.
• Achievable: Quality KPIs should be realistic and attainable, considering the available resources, time, and capabilities.
• Relevant: The KPI should be aligned with the company’s overall strategy, mission, and vision.
• Time-bound: Quality KPIs should have a specific timeframe or deadline for achievement.

Once quality KPIs have been set, companies must diligently track and measure their quality KPIs to analyze the data and ensure that processes are working as intended.

How to Measure Quality KPIs?

There are several ways to measure quality KPIs. Defining the most effective approach to measuring quality KPIs necessitates a comprehensive understanding of a company’s specific requirements and available resources.

The following are some of the most common methods.

Manually Recorded or Spreadsheet-Based

The manual recording of quality KPIs in spreadsheets is a cost-effective initial approach, particularly for businesses with simpler processes. Companies often start with a quality KPI template in a spreadsheet to ensure organized data entry.

However, while this method provides a simple start, it requires careful attention to detail to avoid human error and can be time-consuming. As companies evolve, they should consider transitioning to more modern systems to improve efficiency, reduce errors, and allow more complex analysis.

Periodic Reviews

Periodic reviews are essential for effectively monitoring quality KPIs in systematic evaluations of performance data at regular intervals.

These reviews, which can be conducted weekly, monthly, or quarterly, require that companies actively interpret the data, allowing the identification of trends, deficiencies, and areas for improvement.

Such regular analysis is critical in maintaining an ongoing awareness of quality performance, enabling informed strategic decision-making.

One common type of periodic review is the management review. A quality management review is a formal assessment held by top management to review the company’s quality management system. Management reviews typically include a review of the quality KPIs.

Real-Time Monitoring and Analytics Tools

Automated dashboards and real-time analytics, such as business intelligence (BI) tools, are the most efficient and effective way to measure quality KPIs.

These digital solutions automatically collect and process data as it happens, providing immediate insights into quality-related parameters.

One example is SimplerQMS, a QMS software that streamlines quality processes and facilitates data access. SimplerQMS allows the seamless export of data in CVS format for further analysis or request periodic quality KPI reports.

What Are the Main Benefits of Quality KPI Monitoring?

The main benefit of quality KPI monitoring is to improve evidence-based decision-making. By regularly tracking and analyzing quality KPIs, companies can identify areas where their QMS has performance gaps and develop and implement improvement initiatives.

Moreover, quality KPI monitoring provides several significant benefits for companies.

Here are some more benefits of KPI monitoring:

Better Decision-Making

Quality KPIs provide objective data that supports informed decision-making. When employees have access to accurate and up-to-date KPIs, they can make timely and effective choices that are aligned with the company’s goals.

Improve Efficiency and Effectiveness of the QMS

An effective quality management system is a system that allows a company to reliably provide products and services that comply with customer and regulatory requirements.

KPI monitoring helps identify areas of inefficiency in processes or workflows, improving the efficiency and effectiveness of the QMS.

By analyzing KPI data, companies can streamline operations, reduce waste, and optimize resource allocation, leading to cost savings and improved productivity.

Enhance Customer Satisfaction

Monitoring customer-centric KPIs allows companies to measure how well they meet customer expectations. This information enables them to make improvements that directly impact customer satisfaction.

Increased Visibility

Quality KPI monitoring provides companies with increased visibility into their processes, which helps companies identify and address problems early on and make better decisions about allocating resources.

Identify and Manage Risks

By tracking relevant KPIs, companies can identify trends and patterns related to potential risks. Implementing a proactive approach to risk enables companies to develop mitigation strategies.

Benchmark Company Performance

KPI monitoring allows companies to compare their performance against industry benchmarks and competitors. The benchmarking process provides valuable insights into areas where the company excels and where improvements may be needed to stay competitive.

To fully leverage the potential of quality KPI monitoring, companies can implement quality KPI monitoring software.

What Is the Role of Quality KPI Software?

The role of quality KPI software is to streamline the process of tracking and reporting quality KPIs in real-time while providing a centralized platform for gathering data on various quality parameters.

Nowadays, modern QMS software solutions offer quality KPI tracking capabilities as an integral component of their feature set.

SimplerQMS offers an eQMS software solution that facilitates access to quality KPI data.

Our software provides Life Science companies access to real-time KPI data, allowing for timely decision-making and proactive quality management.

SimplerQMS also provides periodic KPI reports that could be tailored according to the company’s needs.

SimplerQMS software supports Life Science companies to comply with a variety of regulatory requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, and EU GMP.

SimplerQMS solution provides comprehensive QMS process support for document management, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.

To assess the value of an eQMS for your company, we recommend downloading our eQMS Business Case template.

Our template can help you evaluate the benefit of implementing an eQMS for your company and communicate your findings to management. By analyzing potential efficiency increases, cost reductions, and compliance efforts, you can make a strong case for implementing an eQMS.

Final Thoughts

Quality KPIs are specific and measurable metrics that companies use to track the quality of their products, services, or processes. By measuring quality KPIs, companies can identify areas where they need to improve and ensure that they are meeting their quality goals.

Nowadays, many eQMS software simplify access to KPI data, including SimplerQMS.

SimplerQMS is a fully validated (GAMP 5) eQMS solution designed specifically for the needs of Life Science companies. The software includes a dashboard that automatically tracks and displays users’ personal tasks and assignments.

The system allows the creation of personalized views to monitor quality KPI data that accurately reflects the company’s current state. For example, a QA manager could track the number of overdue training or CAPAs that have remained open within the last 30 days.

Discover how SimplerQMS can help your company manage quality. Book a free demo and speak with our quality experts to learn more about how our QMS software can streamline your quality management processes.

The post Quality KPIs in Life Sciences (Quality KPI & Metric Examples) appeared first on SimplerQMS.

The QMS documentation is defined by each company based on regulatory and customer requirements.

This article will discuss QMS documentation, its structure, requirements, benefits of well-documented and implemented documentation, and maintenance. It also explains the role of QMS software in managing QMS documentation effectively.

Life Science companies are increasingly adopting electronic Quality Management Systems (eQMS) to streamline their quality documentation processes.

SimplerQMS provides eQMS software with comprehensive document management capabilities designed for Life Science companies. Schedule a free demo and talk to our quality experts to get a more comprehensive understanding of the QMS software.

We will explore the following topics in more detail.

• What is Quality Management System (QMS) Documentation?
• What is QMS Documentation Structure?
• What Are the QMS Documentation Requirements?
• What Are the Best Practices for QMS Documentation?
• How to Ensure Effective QMS Documentation?
• How to Ensure Continuous Improvement in the QMS Documentation?
• What Are the Essentials for Effective Quality Management System Documentation?
• What Are the Benefits of Well-Documented and Implemented QMS Documentation?
• What Is the Role of QMS Software in Managing Quality Documentation?

What is Quality Management System (QMS) Documentation?

The QMS documentation comprises a set of documents and records that define the company’s Quality Management System (QMS). QMS documentation includes documents related to compliance with applicable requirements, as well as to quality assurance.

The QMS documentation provides a structured approach to quality management, regulatory compliance, and continuous improvement.

The main goal of a QMS is to help ensure that the company complies with applicable requirements. The QMS documentation includes records of how activities were performed as evidence of compliance.

The QMS documentation can be paper-based, hybrid, or electronic. Paper-based and hybrid QMS documentation presents some challenges, such as lack of document control, lack of control of records, lost documents, the need for physical storage, and increased potential for human error.

Software solutions, like SimplerQMS, offer a modern way of working with QMS documentation. Life Science companies can manage and streamline QMS documentation using automated workflows, cloud storage, electronic signatures, and more.

The company must decide which documents are included in the QMS documentation based on relevant requirements. Some examples of QMS documentation include documents that describe a company’s quality policies, processes, procedures, and work instructions.

What is QMS Documentation Structure?

QMS documentation structure is a hierarchical organization of documents within the QMS. The documentation hierarchy makes it easy to understand, communicate, and visualize the documentation structure.

Each documentation level in the structure builds upon the previous one and contributes to the overall effectiveness of the QMS.

As an example, the four levels of documents in the QMS pyramid could include the following:

• Quality policy
• Procedures
• Work instructions
• Records

Quality Policy

The quality policy is a statement that defines the company’s commitment to quality. It is a high-level document outlining the values and principles regarding quality and providing a framework for setting quality objectives.

At SimplerQMS, we advocate for creating quality policies that clearly state the company’s desire to support high and uniform quality in products and processes. It is important for people reading the Quality Policy to see your company’s identity reflected in your quality policy.

Procedures

A procedure describes the step-by-step activities of processes within the company. It includes elements such as the responsible departments or functions and the frequency of the action.

These procedures provide clear guidelines, helping achieve efficiency, quality output, and consistent performance while reducing miscommunication and noncompliance with relevant requirements.

Work Instructions

Work instructions are the most detailed documents in the QMS structure. They describe in detail how specific tasks must be performed.

They are typically written by the people who perform the work or people who are responsible for leading those who perform the work. Work instruction can be developed in the company or provided by customers.

The instructions help ensure tasks are carried out consistently and effectively and meet the applicable requirements of the quality management system.

Records

Records provide evidence that activities and events were conducted, providing a historical record of actions.

By performing internal audits and reviewing the records, companies can support evidence-based decision-making and demonstrate compliance with requirements.

What Is the Difference Between Records and Other Quality Documents in QMS?

The difference between records and other types of documents is that records are evidence of activities performed or results achieved, while other quality documents mostly describe how tasks should be done.

For example, a work instruction describes how a process must be performed, while a record could show how the process was performed, who did it, when, and the result.

Another distinction between records and other types of documents is that records remain unaltered. In contrast, other documents are subject to changes and revisions over time.

As records remain unchanging, it is important to reference the specific versions of the quality documents that were in effect when the record was generated. This ensures that the records accurately reflect the correct QMS documentation at a given time.

SimplerQMS provides eQMS software with comprehensive document control capabilities. New document versions are automatically numbered when created or updated. The system makes it easy to set relations between documents or add links using hyperlinks.

What Are the QMS Documentation Requirements?

The QMS documentation requirements vary depending on the industry. Requirements define which documents must be included in the QMS.

The extent of QMS documentation for a quality management system can differ from one company to another due to its type of activities, processes, products, and services.

The International Organization for Standardization (ISO) provides general guidance for developing and maintaining documentation in the ISO 10013:2021.

The standard gives guidance for managing QMS documentation necessary to support an effective quality system tailored to the company’s specific needs, regardless of the industry in which it operates.

Companies operating in the Life Sciences industries, such as pharmaceutical and medical device companies, must comply with applicable requirements.

What Are the Key QMS Requirements for Pharmaceutical Companies?

ISO 9001:2015

The international standard ISO 9001:2015 specifies the requirements for quality management systems. The ISO 9001:2015 standard requires companies to maintain and retain documented information to support their processes and ensure they are executed as planned.

ISO 9001:2015 is a general standard for quality management systems, and many pharmaceutical companies follow this standard as it provides a structured framework for QMS.

In addition to the requirements of ISO 9001:2015, companies may also have to comply with specific requirements from GxP and/or other requirements.

Examples of QMS documentation required by ISO 9001:2015 include quality policies, quality objectives, design and development planning, nonconformance documents, customer complaints, and more.

FDA 21 CFR Part 211

The FDA regulation 21 CFR Part 211 is the current Good Manufacturing Practice (cGMP) for finished pharmaceuticals.

Regarding QMS documentation, it specifies the requirements for written procedures, records, and reports to be managed and kept readily available for inspection during the retention period.

This regulation requires QMS documentation, such as batch production records, equipment use logs, complaint files, and sanitation procedures, among others.

Read our introductory guide to cGMP if you are interested in learning more about cGMP regulations.

ICH Q10

The ICH Q10 is a guideline describing a model for an effective quality management system for the pharmaceutical industry.

It outlines the requirements for the quality manual, CAPA documents, product discontinuation reports, and more. Compliance with ICH Q10 ensures that the documentation of the pharmaceutical quality management system is well-structured and clear, promoting common understanding and consistent application.

Examples of QMS documents in the ICH Q10 include quality manual, quality policy, CAPA documents, product discontinuation documents, deviation documentation, and more.

Have a look at our comprehensive ICH Q10 article to gain a better knowledge of the pharmaceutical quality system.

What Are the Key QMS Requirements for Medical Device Companies?

ISO 13485:2016

The regulatory standard ISO 13485:2016 outlines the requirements for medical device quality management systems.

Concerning QMS documentation, ISO 13485:2016 requires companies to create and manage documents and records to ensure the effective planning, operation, and control of quality processes.

This standard requires QMS documentation to include quality manuals, medical device files, training records, and complaint handling records, among others.

You can learn more about the ISO 13485:2016 quality system by reading our article about ISO 13485:2016 compliant QMS.

FDA 21 CFR Part 820

The 21 CFR Part 820, also known as the Quality System Regulation (QSR), establishes the requirements applicable to manufacturers of finished medical devices.

The regulation requires manufacturers to establish and maintain procedures to control all documents related to medical devices, including the creation, review, approval, and change processes.

For instance, 21 CFR Part 820 requires QMS documents such as design history files, device master records, nonconformance documents, equipment calibration records, CAPA documents, and more.

Check out our article on medical device quality management systems to learn more about the key requirements and major processes.

What Are the Best Practices for QMS Documentation?

Implementing general best practices for QMS documentation development helps ensure it is accurate, up-to-date, accessible, and easy to understand.

Here are some examples of general best practices when developing QMS documentation.

Make Sure Your Documentation Is Fit-For-Purpose

The QMS documentation should be tailored to the specific needs of the company and its processes, as well as to the intended user’s needs.

Use Clear and Concise Language

The language in the QMS documentation should be clear, concise, and easily understandable.

Avoid technical jargon or complex terminology that may impact comprehension. Aim for simplicity to improve clarity and promote effective communication.

Implement document templates to ensure consistency in process descriptions and instructions across all documents.

For example, SimplerQMS offers eQMS software with the ability to use highly customizable documentation templates for document creation. Companies can use our complementary template package or their existing templates.

Use a Distinct Structure

Documentation must have a clear and logical structure that makes information easy to find. The structure must be consistent throughout the QMS documentation so that users can easily navigate between different documents.

Keep Your Documentation Lean

QMS documents need to be as concise as possible without sacrificing clarity or completeness. Companies should prioritize including only necessary information in the documentation and avoid unnecessary details, redundancies, and lengthy explanations.

Use Visuals

Visuals can be included to help make QMS documentation easier to understand. Companies can incorporate visual aids such as flowcharts, diagrams, and tables to convey complex information efficiently.

Review and Update Your Documentation Regularly

QMS documentation must be regularly reviewed and updated to reflect the company’s current processes, procedures, or requirements changes.

How to Ensure Effective QMS Documentation?

The effectiveness of QMS documentation can be ensured through the following processes:

• Internal audits
• External audits
• Management reviews

Below is a more detailed explanation of how these processes can help to ensure effective QMS documentation.

Internal Audit

Internal audits are conducted by the company itself to identify any gaps or inconsistencies in its QMS documentation and to verify that employees are working in accordance with procedures.

This involves evaluating processes, procedures, and work instructions to verify compliance with applicable requirements. Relevant people conducting the audit may also check records and monitor whether employees work according to procedures in person.

Analyzing records is important to collect evidence that employees are following quality documents and to identify areas for improvement within processes.

External Audits

External audits are conducted by independent auditors, such as certification bodies. These audits assess the adequacy and effectiveness of QMS documentation and alignment with applicable regulatory requirements.

For example, an external audit could be conducted to assess the company’s QMS documentation and its compliance with ISO 9001:2015.

Management Review

Management reviews are conducted by top management to monitor and define the effectiveness, suitability, and adequacy of QMS documentation. Management reviews help to ensure that the documentation is aligned with the company’s quality goals and regulatory requirements.

Not all companies are required to implement management reviews depending on their applicable requirements. Some examples of requirements that specify management review are ISO 13485:2016, 21 CFR Part 820, and ICH Q10.

For companies to whom management reviews apply, management reviews should be periodically performed to assess the overall performance of QMS documentation, typically once a year. This involves evaluating the QMS for effectiveness and adequacy and ensuring sufficient resources for the intended use.

While performing audits and reviews, Life Science companies can detect and address issues within their QMS, allowing them to implement essential improvements as needed.

How to Ensure Continuous Improvement in the QMS Documentation?

To ensure continuous improvement in the QMS documentation, Life Science companies can utilize the PDCA (Plan-Do-Check-Act) cycle.

The PDCA management method consists of four steps:

1. Plan your actions
2. Do what you planned
3. Check that everything has been done correctly
4. Act to implement necessary improvements

The cycle can be repeated as often as necessary to achieve the desired results. It is a powerful tool for continuous improvement as it facilitates learning from mistakes and incorporating corrective actions based on acquired knowledge.

The process of structuring and maintaining QMS documentation within an effective quality management system follows the PDCA cycle.

Following the PDCA cycle, illustrated below, Life Science companies can establish a systematic approach to ensure continuous improvement in the QMS documentation.

What Are the Essentials for Effective Quality Management System Documentation?

Effective QMS documentation requires several essential components to ensure accuracy, accessibility, compliance, and operational efficiency.

The following are some essential processes for creating and maintaining effective QMS documentation, along with examples of how an eQMS such as SimplerQMS further streamlines these processes.

Document Control

Document control is a requirement for all companies and must be in place to manage document creation, review, approval, distribution, and archiving.

This helps ensure that the documentation is controlled, consistently maintained, and organized.

Many regulatory requirements compel companies to have a document management process.

SimplerQMS provides comprehensive document control capabilities, providing pre-defined workflows for document creation, review, and approval. These workflows serve as a guiding framework, assisting users throughout the documentation processes and helping ensure adherence to Life Science requirements.

Implement Version Control

Version control must be implemented to track and manage document revisions.

Clearly indicate the document version number, who modified the document, and the date and time to avoid confusion and ensure the latest version is readily identifiable and accessible.

Versioning of documents is automatically done in SimplerQMS. New or updated documents receive a sequential number for the identification of the latest version. The old document is retired to avoid the use of outdated documents.

Streamline Document Review and Approval

A formal document review and approval process should be utilized to ensure accuracy and compliance with regulatory requirements.

Involve subject matter experts in the review process to obtain valuable input.

With SimplerQMS, document review and approval processes become effortless. The pre-configured system workflows route the documents to assigned personnel together with notifications of required actions.

Ensure Document Accessibility

Only authorized personnel should have access to the required documentation.

Implement a document management system to facilitate document access, search, retrieval, and distribution.

SimplerQMS ensures that access to the system is granted only to authorized individuals, preventing unauthorized access. Employees have unique identification codes and password combinations that periodically need to be updated.

Employ Document Change Management

The change management process needs to be well-defined for document modifications and updates.

For companies that require comprehensive document change management, this process could include steps for reviewing proposed changes, obtaining approvals, communicating changes to relevant persons, and ensuring adequate implementation.

A more rigorous document change management process is necessary for quality documents, as it ensures changes in critical procedures and instructions are made in a controlled and systematic manner.

The SimplerQMS software offers robust change management capabilities. It facilitates the generation, documentation, and management of all changes across the company. Tasks can be created and assigned, electronically signed upon approval, and automated notifications and reminders can be established to ensure the timely fulfillment of change-related processes.

Provide Employee Training

Comprehensive training plans must be conducted to educate employees on the purpose, content, and use of documentation. A skill matrix should be in place to assess employees’ competencies, identify skill gaps, and support the creation of training plans.

By providing effective training, companies equip employees with the necessary skills and knowledge to create, manage, and utilize documentation effectively throughout their roles.

For instance, the SimplerQMS Employee Training Management module allows companies to achieve efficient, well-documented, and compliant training processes. This module includes features such as automated assigning of training activities, email notifications and reminders, training effectiveness assessments, tracking of training progress, and much more.

Conduct Internal Audits

Regularly perform internal audits of the QMS documentation to verify compliance with established procedures and standards. As mentioned above, these audits help identify any issues, gaps, or areas for improvement within the QMS documentation.

With the SimplerQMS Audit Management module, you can create comprehensive audit plans. Create regulatory inspections, supplier audits, and internal and external audits, link them to audit plans, and relate any relevant documents. Moreover, you can monitor all activities associated with audits, ensuring a comprehensive approach to audit management.

What Are the Benefits of Well-Documented and Implemented QMS Documentation?

Some of the key benefits of having adequate QMS documentation are listed below.

• Compliance with requirements: When QMS documentation content follows the applicable requirements it helps companies demonstrate compliance.
• Improved efficiency: Adequate QMS documentation helps to streamline processes and reduce errors, which leads to increased efficiency.
• Reduced costs: Effective documentation facilitates identifying and mitigating risks, reducing the risk of recalls and other regulatory issues.
• Improved communication: Accurate and clear documents ensure everyone understands the quality processes and quality procedures, improving communication and collaboration.
• Increased customer satisfaction: QMS documentation helps to ensure that products and services are uniform and high quality to meet customer requirements.
• Improved decision-making: Effective QMS documentation can provide comprehensive information needed to make informed decisions about quality processes.

While the benefits of QMS documentation are evident, creating and maintaining effective documentation manually presents challenges. QMS software helps to streamline the process and ensure that documentation is accurate, up-to-date, and accessible.

What Is the Role of QMS Software in Managing Quality Documentation?

QMS software plays an essential role in managing quality documentation.

Even though traditional paper-based and hybrid systems can be used by small companies with sufficient resources, these present challenges and limitations. For example, lack of document and record control, lost documents, and the need for physical storage space can lead to inefficiencies and potential data loss.

Due to the complexity involved in the documentation processes, traditional quality systems are being replaced by electronic solutions. Utilizing the eQMS streamlines managing documentation while reducing the risk of lost documents and compliance issues.

SimplerQMS is a fully validated eQMS software solution for Life Sciences designed to simplify and optimize the management of quality documentation, offering a range of features and benefits.

We provide Quality Document Management Software that streamlines the management of QMS documentation. Our system automates workflows for document creation, review, and approval. You can set automatic reminders and notifications for document updates and ensure quality documents comply with applicable regulations and standards.

An essential aspect of QMS documentation is the approval of documents through electronic signatures. SimplerQMS provides 21 CFR Part 11 compliant electronic signatures, allowing secure signing of documents. This process involves unique combinations of user identification codes and passwords to ensure the authenticity and equivalence of electronic signatures to handwritten ones.

Besides 21 CFR Part 11, our QMS platform supports compliance with several Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 210, 211, and 820, EU GMP Annex 11, EU GMP, and more. By providing comprehensive QMS process support, SimplerQMS software helps Life Science companies comply with various regulatory requirements.

Some of the QMS processes supported by the SimplerQMS solution include document management, change control, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.

We suggest downloading our eQMS Business Case template to evaluate the benefits of implementing an eQMS.

You can use this tool to assess the value of an eQMS for your company. Furthermore, it allows you to effectively communicate your findings to management. Such analysis can help you identify potential efficiency increases, cost reductions, and compliance improvements.

Final Thoughts

QMS documentation comprises the documents and records that establish the company’s Quality Management System (QMS). QMS documentation is related to compliance with regulatory and customer requirements and quality assurance aspects.

Electronic systems are replacing paper-based and hybrid systems for managing quality documentation as they offer several benefits. QMS software presents features that streamline QMS documentation management, improving effectiveness and compliance efforts.

SimplerQMS presents QMS software with robust quality management capabilities tailored for Life Science companies. Interconnected processes and pre-defined workflows guide users through the core stages of each process, providing support in ensuring compliance with Life Science requirements.

Learn more about how the SimplerQMS solution can support your company. Book a free demo and talk with our quality experts to better understand how our QMS software can help you streamline your QMS documentation management.

The post Quality Management System Documentation appeared first on SimplerQMS.

Various standards and regulations outline specific requirements for implementing a Quality Management System (QMS) in a laboratory environment, such as ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493.

These standards provide guidelines and criteria for laboratory processes, including testing, calibration, documentation, personnel competency, and overall quality control.

This article will discuss the applicable standards and legislation, the 12 essential elements of laboratory QMS, and the role of QMS software in a laboratory environment.

SimplerQMS provides QMS software solutions tailored for Life Science companies, including clinical and medical laboratories. Book a personalized demo to learn how SimplerQMS can streamline your lab’s quality management processes.

In this article, we will discuss:

• What Is Laboratory Quality Management System?
• Applicable Laboratory QMS Requirements
• 12 Elements of Laboratory Quality Management System (QMS)
• Role of Laboratory Quality Management Software

What Is Laboratory Quality Management System?

A Laboratory Quality Management System (LQMS) is a comprehensive framework of processes, procedures, and practices implemented within a laboratory to ensure overall quality.

It involves systematic planning, control, and monitoring of all activities within the laboratory to comply with regulatory requirements, maintain reliable results, and enhance customer satisfaction.

Laboratory processes that require quality practices include:

• Sample handling and management
• Equipment calibration and maintenance
• Method validation and verification
• Quality control and quality assurance
• Training and competency assessment
• Document control and recordkeeping
• Customer communication and satisfaction
• And more

It is important to distinguish between the Quality Management System (QMS) in the medical laboratory and an Electronic Quality Management System (eQMS).

The laboratory QMS primarily concentrates on overseeing and ensuring quality within the laboratory’s operations. It encompasses processes, procedures, and protocols designed to maintain uniform and high quality and accuracy in testing, analysis, and reporting.

On the other hand, an eQMS offers a digital solution for effectively implementing and managing QMS principles and processes in an electronic format. It serves as a specialized software designed to align with regulatory requirements and streamline the implementation of QMS principles.

In a medical laboratory, an eQMS supports the laboratory quality management system processes such as document management, change control, CAPA management, employee training, and more.

SimplerQMS provides a comprehensive eQMS solution that encompasses all of the features and modules designed to streamline the efficiency of laboratory operations. These modules integrate seamlessly with the overall QMS framework, improving operational efficiency and supporting compliance with regulatory requirements.

Applicable Laboratory QMS Requirements

Various applicable standards and regulations govern laboratory quality management. These ensure that laboratories adhere to specific requirements and maintain a high and uniform level of quality in their processes.

ISO 9001:2015

The ISO 9001:2015 standard is a general requirement for a quality management system.

Although not tailored specifically for medical and clinical laboratories, ISO 9001:2015 requirements can still be followed by these laboratories to consistently deliver products and services that meet customers’ expectations and comply with regulatory requirements.

ISO/IEC 17025:2017

The ISO 17025:2017 standard establishes the requirements for testing and calibration laboratories to demonstrate their competency in testing and equipment calibration.

Compliance with this standard indicates that a laboratory possesses the necessary knowledge, skills, and resources to produce reliable and valid results.

It ensures that testing and calibration activities are conducted with impartiality, competence, and consistent operational practices. This way, laboratories can enhance their credibility, inspire confidence in their clients, and demonstrate their commitment to quality and accuracy.

ISO 15189:2022

The ISO 15189:2012 provides laboratories with a framework to develop robust lab quality management systems and assess their own competence.

This standard aims to promote the welfare of patients and the satisfaction of laboratory users through confidence in the quality and competence of medical laboratories.

ISO 15189:2012 covers a wide range of requirements, including but not limited to:

• Quality Manual
• Personnel training
• Equipment calibration
• Nonconformances
• Complaints
• Data retrieval and storage
• Environmental conditions
• Examination processes
• Risk management
• Control of records
• Management reviews

Learn more about this standard in our detailed introduction to ISO 15189:2022 article. In it, we discuss this standard’s purpose, requirements, and all aspects to provide a comprehensive understanding.

ISO/IEC 17043:2010

The ISO 17043:2010 standard focuses on proficiency testing and sets forth the requirements for laboratories to participate in interlaboratory comparisons.

Laboratories can test identical or similar samples under predetermined conditions, allowing them to evaluate their performance, identify areas for improvement, and demonstrate their competence in delivering accurate and reliable results.

CLSI HS01-A2

The Clinical and Laboratory Standards Institute (CLSI) HS01-A2 guideline specifies the requirements for a QMS model for healthcare organizations.

It offers essential background information and infrastructure to establish a quality management system aligned with healthcare quality objectives.

Implementing this guideline, along with other relevant CLSI documents, allows Life Science companies to apply the model to their unique processes.

CLSI GP26-A3

The CLSI GP26-A3 guideline outlines the requirements for applying a QMS model for laboratory services.

It is a useful resource for improving clinical laboratory processes, workflow, and operations, meeting government and accreditation requirements.

Combined with the CLSI HS01-A2, it provides a comprehensive framework for laboratories to implement a complete quality management system.

WHO Laboratory QMS Handbook

The World Health Organization (WHO) laboratory QMS handbook is a comprehensive reference on quality management systems in medical and clinical laboratories.

This handbook is based on the ISO 15189:2022 and CLSI GP26-A3 documents. It covers crucial topics necessary for effective quality management in public health or clinical laboratories.

The LQMS handbook supports the needs of management, administration, and bench-work laboratorians by offering a framework, valuable insights, and guidance to fulfill their roles and responsibilities effectively.

FDA 21 CFR Part 58

The 21 CFR Part 58 establishes Good Laboratory Practices (GLP) for nonclinical laboratories involved in research related to food and color additives, animal food additives, human and animal drugs, human medical devices, biological products, and electronic products.

Compliance with this part is intended to assure the quality and integrity of the products and substances’ safety data.

Clinical Laboratory Improvement Amendments (CLIA)

The CLIA refers to a series of adjustments made to the Public Health Services Act by the US Congress over time.

These amendments have been implemented to safeguard the accuracy and reliability of testing conducted in laboratories that perform testing on humans.

CLIA requirements are listed in 42 CFR Part 493, as listed below.

FDA 42 CFR Part 493

The 42 CFR Part 493 is designed to ensure that medical and clinical laboratories that perform testing on humans operate safely and efficiently and produce accurate and reliable results.

It requires laboratories to have a comprehensive quality management system that includes policies and procedures for all aspects of laboratory operations.

Among the requirements outlined in this part of the regulation are:

• Sample control procedures
• Complaint investigations
• Quality control and quality assurance
• Proficiency testing
• Personnel competency
• Equipment calibration
• Corrective and preventive actions
• Test reporting
• And more

12 Elements of Laboratory Quality Management System (QMS)

The 12 elements of a laboratory quality management system are the building blocks for a QMS framework in medical and clinical laboratories.

Developed by the Clinical and Laboratory Standards Institute (CLSI), these quality elements are integral to laboratory QMS effectiveness.

Neglecting any of these elements can compromise the success of the LQMS. Possibly leading to potential failures in achieving accurate and reliable laboratory results, maintaining regulatory compliance, and meeting customer expectations.

The quality system essentials are illustrated in the diagram below.

The following are the 12 essential elements of a laboratory quality management system, along with examples of how an eQMS, like SimplerQMS, streamlines these processes.

Organization

The organization refers to the laboratory’s management and the supporting organizational structure that facilitates the implementation of quality management practices.

Management must actively support the laboratory QMS and emphasize its significance to the personnel. The management must also ensure the laboratory possesses legal approval from regulatory authorities for its design and operations.

The key organizational requirements for a successful quality system are listed below:

• Leadership: Lab leaders must demonstrate commitment, vision, team-building skills, effective communication, and responsible resource management.
• Organizational structure: The organizational structure should be well-defined, with a clear organizational chart and assigned responsibilities.
• Planning process: Lab managers should have skills for effective planning, including defining timeframes, allocating responsibilities, managing resources, and financial planning.
• Implementation: Management personnel should address project management, resource allocation, adherence to timelines, and goal achievement.
• Monitoring: There should be processes for monitoring the quality management system, ensuring compliance with benchmarks and standards, and continuous improvement is important.

Personnel

Personnel is the most valuable resource in the laboratory. Their integrity, understanding of the importance of their work, and active participation in continuous improvement are essential for successfully implementing the quality management system.

Management is responsible for defining suitable qualifications for personnel in every laboratory position. Additionally, they must ensure that personnel receives proper training to meet education, skills, knowledge, and experience requirements.

Employees must undergo a performance evaluation to assess their competency, including policy adherence, safety compliance, communication skills, punctuality, and behavior.

The laboratory should maintain confidential employee records related to their work. In contrast, non-essential records may be stored with centralized departments like Human Resources.

SimplerQMS provides robust training management capabilities. The system automates training activities and securely stores employee records while ensuring GDPR compliance.

It streamlines the entire training process, from creating training plans and learning rules to tracking training deadlines and completion status.

Automated notifications for new training materials simplify staying up to date. Upon completion, personalized quizzes can be used to evaluate the effectiveness of the training.

Equipment

Effective equipment management is essential to a laboratory QMS, ensuring the laboratory’s ability to conduct accurate, reliable, and timely testing.

By implementing proper equipment maintenance, calibration, and documentation protocols, laboratories can ensure the integrity of their testing processes and the optimal performance of their equipment.

When it comes to equipment management, careful planning is essential.

Several key elements should be considered in the equipment management process:

• Selection and purchasing: Laboratories should establish criteria to select equipment according to the applicable requirements.
• Installation: Requirements for installing new equipment should be followed, and specific personnel should handle the installation.
• Calibration and performance evaluation: Laboratories should perform equipment calibration and validation in new and existing instruments.
• Maintenance: Laboratories should implement maintenance plans following manufacturer guidance.
• Troubleshooting: A clear procedure should be in place for troubleshooting equipment issues.
• Service and repair: The laboratory should assess the costs involved in obtaining service and repair for its equipment. Furthermore, it should assess the availability of such facilities in its area.
• Retiring and disposing of equipment: Laboratories should have procedures for replacing old equipment and ensuring proper disposal.

A technical operator is responsible for overseeing equipment in the laboratory, ensuring proper troubleshooting and maintenance.

The laboratory must maintain a logbook with essential details about equipment, including tests performed and personnel involved.

Using SimplerQMS software, medical and clinical laboratories can streamline calibration and maintenance activities and ensure compliance with regulatory requirements.

The software streamlines equipment management tasks, such as equipment registration and qualification, making it easier for laboratories to maintain accurate information on their equipment.

It keeps track of calibration data and automatically sends notifications and reminders before calibration becomes due.

Furthermore, it allows assigning the responsibility of calibration and maintenance to appropriate personnel.

Purchasing and Inventory

Constant availability of reagents, supplies, and services is crucial for efficient and cost-effective laboratory operations. Any interruption in testing, even for a short period, can severely impact clinical care, prevention activities, and public health programs.

Establishing policies and procedures for managing critical materials and services is essential for successful purchasing and inventory management.

Some of the key components to address are:

• Supplier qualifications
• Purchase agreements
• Receiving, testing, storing, and handling materials
• Tracking materials to individual patients
• Assessing and maintaining inventory
• Controlling expiration periods
• Dispatching supplies to satellite laboratories
• And others

A successful purchasing and inventory management system in a laboratory quality management system can be achieved through the following actions:

• Assigning responsibility
• Evaluating laboratory needs
• Establishing minimum stock requirements
• Implementing electronic forms and logs
• Adopting a digital system for receiving, inspecting, and storing materials
• Maintaining an inventory system across all storage areas

For example, licensed drug manufacturers and laboratories must justify their stock levels of restricted chemicals to local drug regulatory authorities. Maintaining logs and forms ensures compliance and prevents penalties from regulatory bodies.

With SimplerQMS, laboratories can effectively manage their supplier selection process by evaluating and qualifying suppliers based on relevant performance criteria. It facilitates the maintenance of an approved supplier list (ASL) and offers templates for contracts, surveys, and supplier evaluations.

Additionally, the software sends automatic notifications and reminders for upcoming supplier certificate renewals.

SimplerQMS streamlines the entire supplier qualification process, allowing laboratories to categorize suppliers, perform qualification tasks, and conduct reviews seamlessly.

Process Control

The key factor that determines the success and performance of a laboratory is its ability to manage and control all of its processes effectively.

Sample management is essential to process control within a quality management system in laboratories.

Effective sample management is crucial for accurate and reliable testing, leading to confident laboratory diagnosis. Precise laboratory results are essential for making informed therapeutic decisions and ensuring optimal patient care and outcomes.

The sample collected must be standardized and represent the actual condition. The sample must be stored in recommended storage conditions to prevent damage as soon as it is collected.

Sample management policies must include the following:

• Information on the sample collection
• How to handle urgent requests
• Sample collection, labeling, preservation, and transport procedures
• Safety practices in case of accidents
• Methods for evaluating, processing, and tracking samples
• Storage, retention, and disposal procedures
• Among others

It is essential to manage sample documents effectively to avoid any mix-ups or discrepancies that could lead to incorrect testing outcomes. Important information such as sample identification, collection data, time, and required tests should be documented accurately.

To facilitate efficient sample management and document control, SimplerQMS has robust document management capabilities.

These features help streamline quality processes, ensuring all necessary information is recorded and accessible. By using SimplerQMS, laboratories can improve their document management practices and reduce the risk of errors or misinterpretations during testing.

Information Management

Information management is a comprehensive system encompassing all the necessary processes for efficiently managing patient data, including incoming and outgoing information.

Test results and data are the final product of laboratory operations. To ensure accessibility, accuracy, timeliness, security, confidentiality, and privacy of patient information, laboratories must establish an efficient information management system.

When developing an information management system, it is important to consider the following key elements:

• Unique identifiers for patients and samples: The same identifier should be used every time a patient utilizes the service. Similarly, a unique identifier should be generated for every sample collected.
• Standardized test request forms: Consistent forms must be used to request specific tests, ensuring clarity and accuracy in the information provided.
• Logs and worksheets: Detailed records should be maintained to track the flow of samples, test results, and any relevant observations or actions taken during the process.
• Checking processes to ensure data recording and transmission accuracy: Procedures should be in place to verify the correctness of recorded data and its proper transmission within the information management system.
• Protection against data loss: Measures such as regular backups and data recovery mechanisms must be implemented to safeguard data from loss.
• Protection of patient confidentiality and privacy: Strict protocols should be followed to maintain the confidentiality and privacy of patient information per applicable regulations and ethical considerations.
• Effective reporting systems: Systems must be established to generate comprehensive and meaningful reports based on the collected data, facilitating analysis, decision-making, and communication of results.
• Effective and timely communication: Efficient communication channels should be established to ensure a timely exchange of information among relevant laboratory personnel and patients.

SimplerQMS offers a form and template management capability that can help improve the efficiency of laboratory information management processes.

With pre-defined forms for patient information, logs, and results, laboratories can streamline data collection.

The system offers a search function to retrieve relevant documents by searching keywords in the document title and content, such as name or patient number.

Documents and Records

Document and record management is an essential component of the quality system, encompassing the utilization and maintenance.

The primary objective of maintaining QMS documentation is to ensure immediate access to information whenever required.

Documents need to be regularly updated, and an effective document control system ensures that the latest versions are accessible and in use.

Some examples of documents and reports include:

• Quality manuals
• Standard operating procedures (SOP)
• Work instructions
• Reference materials
• Sample logbook
• Patient test reports
• Incident reports
• Instrument printouts

An automated document control software solution helps ensure precise data collection by providing a streamlined and efficient process.

SimplerQMS offers Life Science eQMS with robust document control capabilities, for clinical and medical laboratories, enabling them to maintain audit-ready documents while accurately managing large volumes of data.

By utilizing the eQMS, laboratories can enhance data accuracy and reliability, improving decision-making and operational excellence.

The system facilitates easy retrieval of documents and ensures proper archiving when documents are updated.

Explore our article on laboratory document control to learn more about the importance of proper document management in ensuring accurate and reliable results.

Occurrence Management

Occurrence management is essential for maintaining quality laboratory service by effectively addressing and learning from errors. It is integral to continual improvement, focusing on identifying and managing errors or near misses.

An occurrence management program aims to correct errors in testing or communication that result from an issue and prevent their reoccurrence by improving the processes involved.

The laboratory should establish a proper system for timely investigation of all laboratory issues and errors and occurrence management, including the following:

• Establish a systematic process to detect all problems using available tools.
• Maintain a comprehensive log of problem events, documenting errors, investigation activities, and actions taken.
• Investigate and analyze the cause of identified problems, utilizing available information.
• Implement necessary corrective actions, including preventive measures, if the problem is identified before the error occurs.
• Detect and monitor any reoccurrence of the initial problem, considering potential systemic issues.
• Communicate relevant information to all stakeholders, including those affected by the error.

Occurrence management, also called incident management, is essential to every laboratory as it affects the quality of laboratory testing and results.

SimplerQMS automates the recording and tracking of nonconformances, ensuring efficient handling of identified issues.

The system also automates the notifications and reminders, ensuring that the relevant personnel is promptly informed when nonconformance tasks are assigned. This promotes accountability and facilitates timely action on identified issues.

Moreover, SimplerQMS allows you to seamlessly link nonconformances to Corrective and Preventive Action (CAPA) processes. This integration allows for the systematic resolution of issues and the implementation of preventive measures to avoid their recurrence in the future.

The software allows for comprehensive monitoring of nonconformances by product, process, customer, equipment, or supplier. Customizable views provide flexibility in analyzing and tracking nonconformances, facilitating data-driven decision-making and continuous improvement efforts.

Assessment

Assessment evaluates the effectiveness of a laboratory’s quality management system through internal and external audits and performance evaluation in external quality assessment programs.

There are two types of audits: internal and external.

Internal audits are conducted by personnel within the laboratory itself. Individuals from one department assess the operations of another department. The main objective of these internal audits is to identify and address any potential weaknesses or areas of improvement.

In contrast, external professionals and experts who specialize in their respective fields conduct external audits. These audits have many purposes, such as accreditation, certification, and licensing.

The involvement of external auditors ensures impartiality and brings an objective perspective to assess the laboratory’s compliance with standards and regulations.

With SimplerQMS, laboratories can streamline the audit process, saving valuable time and effort in achieving successful audit outcomes.

The software simplifies creating audit plans, scheduling audits, assigning dedicated Issue Handlers, and attaching relevant evidence to audit findings.

It provides a closed-loop workflow by directly escalating audit findings to Corrective and Preventive Actions (CAPAs), ensuring that issues are promptly addressed and resolved.

To learn more, you can explore our article on laboratory audits which provides an overview of this topic.

Process Improvement

Process improvement is a vital component of a quality management system, as it establishes a structured program to drive continuous improvement in laboratory quality over time.

The Plan-Do-Check-Act (PDCA) cycle is a valuable tool for achieving continuous improvement in any process within quality improvement efforts.

The cycle consists of four key steps:

• Plan: Identify problems and potential weaknesses and gather relevant information to develop an improvement plan.
• Do: Implement the developed plan and put it into action.
• Check: Monitor and assess the effectiveness of the actions taken, utilizing review and audit processes. Revise the plan if necessary.
• Act: Take any required corrective actions based on the evaluation and recheck the results to ensure the effectiveness of the solution. This cycle is a continuous process, initiating further planning for ongoing improvements in the laboratory.

The ISO 15189:2022 in section 4.12 specifies a comparable set of activities for achieving continuous improvement within the laboratory. These are outlined as follows:

• Identify potential sources of system weaknesses or errors
• Develop improvement plans
• Implement the plan
• Review the effectiveness of actions through focused review and audit
• Adjust the action plan and modify the system based on review and audit results.

Processes like internal and external audits, external quality assessments, and management reviews are used to identify opportunities for improvement and can serve as the basis for Corrective and Preventive Action (CAPA).

CAPA offers a systematic approach to tracking corrective actions and their effectiveness. However, manually handling CAPA processes can lead to delays and incomplete actions. Implementing an automated CAPA system can significantly improve this process.

SimplerQMS offers a comprehensive CAPA management software solution that simplifies and automates the corrective and preventive action process. Laboratories can streamline CAPA activities such as data collection, routing, notifications, approvals, and follow-up, ensuring efficient and effective management of quality issues.

The software provides a centralized platform to track CAPAs, monitor progress, and generate insightful reports, helping laboratories drive continuous improvement and achieve regulatory compliance.

Customer Service

Customer satisfaction is a major aspect of a quality management system. The primary objective of a medical laboratory is to provide quality test results to its customers, making it essential to ensure their satisfaction.

To achieve this, the laboratory should clearly understand its clients, including patients, physicians, public health agencies, and the community. Additionally, the laboratory should remain attentive to customers’ needs and requirements.

The laboratory quality manager is accountable for measuring customer satisfaction through surveys, indicators, and audits. They are also responsible for taking proactive measures to prevent and correct any issues identified during the assessment process.

Implementing customer feedback systems enables the collection of real-time data on customer satisfaction levels.

Customer complaints are a common form of customer feedback.

With SimplerQMS’s complaint management solution, laboratories can efficiently track, manage, analyze, and resolve complaints within a single system.

It offers the convenience of storing all related documents in a cloud-based platform, enabling seamless access from anywhere.

The software automatically sends notifications to the appropriate personnel, ensuring prompt attention to customer feedback. It provides valuable insights into feedback data, enabling effective utilization for product improvement and increasing customer satisfaction.

Facilities and Safety

The laboratory workspace and facilities should be designed to accommodate the workload while ensuring the quality of work and the safety of laboratory personnel.

Neglecting laboratory safety can result in significant costs and adverse consequences, such as:

• Loss of reputation
• Loss of customers
• Low staff retention
• Increased costs related to human resources.

The laboratory manager is responsible for both safety and quality in the laboratory. This includes actively participating in lab design, assessing potential risks, and providing valuable feedback to ensure the development of a safe laboratory environment.

Risk assessment is essential for the laboratory to manage and minimize risks to employees effectively. Developing clear safety procedures for handling accidents, injuries, and contamination is vital.

SimplerQMS can help laboratories identify and assess potential risks associated with processes, equipment, personnel, and patient safety.

SimplerQMS Risk Management module allows laboratories to develop risk mitigation plans by defining appropriate control measures, implementing preventive actions, and establishing contingency plans.

The software enables documenting risk mitigation strategies and assigning responsibilities to ensure effective implementation.

Role of Laboratory Quality Management Software

The purpose of laboratory quality management software is to streamline and improve quality processes within laboratories. This specialized software is a comprehensive solution that allows companies to manage and streamline laboratory operations, ensuring compliance with regulatory standards and industry best practices.

The software supports the 12 essential elements of the quality management system in medical laboratories by providing a unified platform for efficiently managing documents, equipment, personnel, processes, testing activities, and other processes.

While eQMS for laboratories offers significant advantages, it is important to consider that a manual and hybrid approach may still be suitable for some companies, especially those with limited resources or specific operational requirements.

The decision to adopt QMS software should consider the laboratory’s specific needs, resources, and regulatory requirements.

SimplerQMS is specifically designed for Life Sciences, including medical and clinical laboratories. It provides robust support for compliance with several Life Science requirements.

With its interconnected QMS modules, SimplerQMS offers key functionalities that align with the 12 essential elements of a laboratory quality management system. These modules include document management, employee training, nonconformance management, CAPA management, audit management, risk management, and more.

SimplerQMS is a fully validated solution, validated according to ISPE GAMP5 guidelines.

This means that all software validation processes are handled by SimplerQMS, eliminating the need for customers to allocate additional resources, time, or costs for software validation.

Additionally, SimplerQMS provides pre-configured workflows, templates, and ongoing support to facilitate a smooth implementation and utilization of the software. This helps laboratories manage their quality management system efficiently, achieve compliance, and drive continuous improvement.

To better understand the benefits of implementing an eQMS solution, we suggest downloading our eQMS Business Case template.

This valuable tool provides a structured approach for assessing the value of an eQMS tailored to your company’s needs, facilitating effective communication of your findings to management.

Using a business case analysis, you can uncover potential ROI, cost savings, efficiency increase, and compliance improvements, including compliance with standards and regulations.

Final Thoughts

Laboratory QMS software streamlines quality processes in laboratories, helping ensure compliance with standards and regulations.

It facilitates effective quality management in medical laboratories by supporting the 12 essential elements of quality management systems.

Implementing QMS software can significantly facilitate the implementation of quality processes, especially when compared to traditional paper-based and hybrid methods.

Working in a medical or clinical laboratory demands handling large amounts of data and information, including various documents, reports, and written materials. Control over these documents is crucial to maintain work quality and comply with regulatory requirements.

With robust security features, SimplerQMS allows users to work efficiently with their documentation, helping ensure compliance with Life Science requirements.

If you are interested in learning more about we encourage you to book a personalized demo and talk to SimplerQMS Quality Solution experts.

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