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Companies facing challenges with paper-based and hybrid QMS, like lost documents, outdated records, and inefficient processes, can benefit from implementing an eQMS.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.

What is the Definition of Quality Management System (QMS)?

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS ensures that products or services are consistently in compliance with customer and regulatory requirements. It achieves this by maintaining records of activities, which serve as evidence that quality-related tasks are being systematically performed.

A Quality management system encompasses the planning, quality control, quality assurance, and improvement of quality across various operations, aiming to enhance customer satisfaction and improve compliance with regulatory requirements.

An objective of a QMS is to manage a company’s activities to comply with customer and regulatory requirements while continuously improving effectiveness and efficiency through the systematic management of quality-related activities.

What Are the Different QMS Formats?

QMS can be implemented in various formats – electronic, paper-based, and hybrid, each catering to different organizational needs and preferences.

Below is an overview of the three primary QMS formats.

Electronic Quality Management System (eQMS)

Electronic Quality Management System (eQMS) refers to a digital solution designed to streamline and automate the quality management processes within a company.

The most common variations of the term “Electronic Quality Management System (eQMS)” are listed below.

• eQMS
• eQMS software
• QMS software
• Digital QMS
• Quality management software

An eQMS comprises a suite of QMS tools, which are essentially software modules and predefined workflows designed to automate and streamline specific quality management processes.

QMS software typically integrates various quality management elements, such as document control, change control, training management, corrective and preventive actions (CAPA) management, audit management, supplier management, and many others.

SimplerQMS offers comprehensive eQMS software tailored to the unique needs of Life Science companies. Book a demo with our Quality Solution consultants to learn more.

Paper-Based QMS

Paper-based QMS relies on physical documents for recording and tracking quality-related information.

Paper-based QMS offers simplicity and physical documentation and may be more cost-effective and accessible for some smaller companies. However, for larger companies, paper-based QMS can be less cost-effective in document control, scalability, and efficiency.

Hybrid QMS (Paper-Based and Electronic QMS)

Hybrid QMS combines elements of both paper-based and electronic systems in its framework for managing quality management processes.

In the hybrid QMS system, certain quality management processes and documentation are maintained in traditional, physical formats, while others use electronic tools and technologies.

Hybrid QMS allows companies to benefit from the familiarity of paper-based systems while incorporating the advantages of digital tools.

This hybrid strategy balances innovation with tradition, offering flexibility but risking inefficiency and data inconsistency in managing dual systems.

Why is Quality Management System (QMS) Important?

A Quality Management System is a requirement in several regulations, standards, and guidelines across multiple industries.

A QMS supports companies in achieving and maintaining compliance with customer and regulatory requirements. It ensures a company consistently delivers uniform and high-quality products or services.

By creating and implementing a QMS, companies gain multiple benefits, such as improving efficiency, ensuring compliance, reducing waste, decreasing costs, enhancing customer satisfaction, and ultimately achieving business growth and success.

What are the Benefits of Quality Management Systems?

The benefits that Quality Management Systems give companies result in more efficient, cost-effective, and safe processes.

The main benefits of QMS are listed below.

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Improved Regulatory Compliance: QMS ensures that companies adhere to industry regulations, standards, and guidelines, reducing the risk of non-compliance and associated legal consequences.

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Improved Customer Retention and Satisfaction: QMS enhances customer satisfaction by consistently delivering uniform and high-quality products or services, fostering loyalty, and increasing the likelihood of repeat business.

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Promoted Continuous Improvement: QMS encourages a culture of continuous improvement, empowering companies to identify areas for improvement, implement changes, and optimize processes over time.

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Developed Operational Consistency: QMS establishes standardized processes, leading to consistent and reliable outcomes, reducing variability, and ensuring a uniform approach across operations.

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Enhanced Internal Communications: QMS promotes effective communication within the company, ensuring that all stakeholders are well-informed, leading to improved collaboration and teamwork.

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Streamlined Employee Training: QMS provides a structured framework for employee training, ensuring that staff members are adequately trained and qualified to perform their roles efficiently.

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Increased Efficiency and Reduced Waste: QMS identifies and eliminates inefficiencies, resulting in streamlined processes, reduced waste, and optimized resource utilization, ultimately contributing to cost savings.

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Improved Decision-Making: QMS facilitates data-driven decision-making by providing insights into processes and performance, enabling informed and strategic decision-making at all levels.

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Improved Company Culture: QMS fosters a culture of quality, accountability, and continuous improvement, creating a positive work environment and aligning employees with organizational goals.

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Increased Profits: QMS contributes to increased profitability through improved efficiency, customer satisfaction, and reduced costs, positioning companies for sustainable growth and financial success.

What are the Different Types of Quality Management Systems?

There are various types of Quality Management Systems, each tailored to the specific needs and requirements of the implementing company. The nature of a QMS depends significantly on the industry in which the company operates and the applicable regulatory and customer requirements.

What are the Types of QMS for Different Industries?

Different industries have specific quality requirements that their QMS needs to reflect. The types of QMS implemented across various industries are further described below.

Life Science Quality Management System

A Life Science QMS is a formalized system tailored to document processes, procedures, and responsibilities specifically for the Life Science industry.

The objective of a Life Science QMS is to ensure that products and services in the Life Science sector consistently comply with regulatory and customer requirements regarding quality, safety, and efficacy.

Pharmaceutical Quality Management System

A Pharmaceutical QMS is a structured system designed to manage organizational processes, documentation, responsibilities, and procedures within a pharmaceutical company.

The aim of a Pharmaceutical QMS is to ensure product quality and safety throughout the pharmaceutical manufacturing process in compliance with regulatory requirements, such as Good Manufacturing Practices (GMP).

Medical Device Quality Management System

A Medical Device QMS is a formalized system designed to document the policies, procedures, and processes implemented by a medical device manufacturer to guarantee the safety and effectiveness of their product’s intended use throughout its lifecycle.

The Medical Device QMS goal is to ensure the safety and effectiveness of medical devices throughout their lifecycle, from design and development to manufacturing, distribution, and end-use.

Laboratory Quality Management System

A Laboratory QMS is a structured framework tailored to document processes, procedures, and responsibilities within laboratory settings, ensuring that testing, analysis, and research activities are consistently accurate and reliable.

The objective of a Laboratory QMS is to ensure accurate and reliable test results, maintain data integrity, and achieve compliance with customer and regulatory requirements.

Clinical Quality Management System

A Clinical QMS is a formalized system designed to manage processes, procedures, and responsibilities within clinical research, clinical trials, and healthcare settings, ensuring clinical trials’ quality, integrity, and safety.

Clinical QMS is often integrated into the broader QMS of pharmaceutical and medical device companies. This integration is essential because clinical trials are a critical component in the development and approval process for both pharmaceutical drugs and medical devices.

The Clinical QMS goal is to ensure patient safety, data integrity, and compliance with customer and regulatory requirements throughout the clinical trial process and healthcare delivery.

Food and Beverage Quality Management System

A Food and Beverage Quality Management System is a structured system to document procedures, processes, and responsibilities designed to ensure food and beverage products’ consistent quality and safety throughout the entire supply chain.

The objective of Food and Beverage QMS is to ensure the uniform and high quality of products from farm or source to processing, manufacturing, packaging, and distribution in compliance with customer and regulatory requirements.

Automotive Quality Management System             

An Automotive Quality Management System is a structured system designed to document processes, procedures, and responsibilities within the automotive industry. It ensures that vehicles and automotive components maintain quality, safety, and reliability.

The aim of an Automotive QMS is to establish and maintain processes that guarantee the quality, safety, and performance of automotive products in compliance with customer and regulatory requirements.

Aviation, Space, and Defense Quality Management System

An Aviation, Space, and Defense Quality Management System is a formalized system to manage policies, processes, and documentation implemented within the aerospace and defense industry.

The goal of an Aviation, Space, and Defense QMS is to ensure customer and regulatory compliance with requirements regarding the safety of aircraft, spacecraft, weapons systems, and related products.

What are the Different Requirements for Quality Management Systems?

Different quality management standards, regulations, and guidelines outline the specific requirements for QMS. Some of these QMS requirements are industry-specific, while others serve as more general-purpose frameworks applicable across various industries.

Examples of the requirements for QMS are described below.

ISO 9001:2015

The ISO 9001:2015 standard establishes the general requirements for the quality management systems.

ISO 9001:2015 is a wide-ranging standard and is applicable across various industries. Moreover, the ISO 9001 standard is frequently utilized by pharmaceutical companies to outline the requirements for their QMS.

ISO 13485:2016

The ISO 13485:2016 standard outlines the requirements for a Quality Management System in the manufacturing of medical devices.

The ISO 13485:2016 compliant QMS provides a framework that enables companies involved in the design, development, production, installation, and servicing of medical devices to deliver safe and effective products consistently.

FDA 21 CFR Part 820

The FDA 21 CFR Part 820 is a regulation, specifically known as the Medical Device Quality System Regulation (QSR), established by the United States Food and Drug Administration (FDA).

The FDA 21 CFR Part 820 QSR specifies the Current Good Manufacturing Practices (cGMP) requirements for medical devices.

FDA 21 CFR Part 820 applies to medical device manufacturers who intend to distribute medical devices in the United States commercially.

ISO 15189:2022

The ISO 15189:2022 standard specifies the requirements for quality and competence in medical laboratories, including requirements for the quality system.

The ISO 15189:2022 applies to medical laboratories, ensuring the accuracy, reliability, and quality of laboratory services, ultimately contributing to patient safety and well-being.

ISO 17025:2017

The ISO 17025:2017 standard specifies the general requirements for laboratories’ competence, impartiality, and consistent operations. The ISO 17025:2017 standard outlines the requirements for the management system and related documentation.

ISO 17025:2017 applies to testing and calibration laboratories performing a wide range of analyses or measurements. Laboratories following the ISO standard can encompass a range of fields, including those within the Life Sciences.

ICH Q10

The ICH Q10 guideline establishes the requirements for the Pharmaceutical Quality System (PQS). ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system.

The ICH Q10 PQS applies to the pharmaceutical and biopharmaceutical companies involved in the development and manufacture of drug substances (APIs) and drug products.

What are the Different Approaches and Methodologies of QMS?

Quality Management Systems encompass various approaches and methodologies that companies can adopt to manage their quality processes. Multiple QMS approaches and methodologies may be utilized, either in full or partially, depending on the company’s specific requirements and needs.

Some of the different approaches and methodologies are as follows.

Continuous Quality Improvement (CQI)

Continuous Quality Improvement (CQI) is an approach to consistently identify areas for improvement and implement changes to improve efficiency, effectiveness, and customer satisfaction.

CQI applies across various industries and is particularly beneficial in sectors where ongoing optimization is essential for meeting evolving regulatory and customer requirements.

While CQI is not mandatory, it is widely recognized as a best practice for companies aiming to foster a culture of continuous learning and improvement.

Total Quality Management (TQM)

Total Quality Management (TQM) is a quality management approach to achieve continuous improvement in the quality of products, services, and processes.

TQM involves the active participation of all employees throughout all company departments, emphasizing teamwork and a commitment to excellence. It applies to various industries and sectors, focusing on creating a culture of quality and continuous improvement.

Although not mandatory, TQM is often used when companies seek a comprehensive and holistic strategy to improve their processes and outcomes.

Lean Manufacturing

Lean Manufacturing is a production methodology focused on minimizing waste and maximizing efficiency. Lean Manufacturing principles are often used when companies aim for a more efficient and cost-effective production system.

The purpose of Lean Manufacturing is to eliminate non-value-added activities, reduce lead times, and enhance overall productivity. Lean Manufacturing applies to manufacturing industries, such as automotive and electronics, where companies seek to streamline operations and improve resource utilization.

While not mandatory, many organizations voluntarily adopt Lean Manufacturing to improve competitiveness and customer satisfaction.

Six Sigma

Six Sigma is a methodology that uses data management and statistical techniques to identify and eliminate defects in processes. Six Sigma follows a DMAIC cycle (Define, Measure, Analyze, Improve, Control) for continuous improvement.

Six Sigma aims to reduce defects and waste, ultimately improving process efficiency and quality.

Six Sigma is not mandatory and can be applied by any company that seeks to improve quality and reduce errors, particularly in manufacturing.

Six Sigma and Lean Manufacturing often complement each other, with companies integrating principles from both methodologies to achieve synergistic benefits.

Agile Quality Management

Agile Quality Management is an approach ideal for projects requiring flexibility and adaptation to changing requirements.

Agile Quality Management aims to foster flexibility, collaboration, and adaptability in delivering uniform and high-quality products or services.

While Agile Quality Management is not mandatory, many companies implement the approach to respond more effectively to changing requirements and deliver products or services that better meet customer needs.

What are the Core Elements of a Quality Management System (QMS)?

A Quality Management System consists of several core elements or modules that work together to ensure that a company’s products or services consistently comply with regulatory and customer requirements.

A QMS should reflect the specific processes and requirements applicable to a company and the industry in which it operates. Some components of a QMS are required by standards, regulations, and guidelines, while others are optional.

Some of the core elements of a QMS are further described below.

Document Control

Document control ensures that all quality-related documents and records are controlled, accessible, and up-to-date.

Document control encompasses both document and record, ensuring that relevant documentation, such as policies, procedures, work instructions, and specifications, are created, reviewed, approved, updated, and retired as necessary.

By establishing robust document control procedures, companies can mitigate the risk of errors, inconsistencies, and outdated information. Additionally, effective document management facilitates transparency, accountability, and traceability.

Change Management

Change management is the systematic approach to implementing new initiatives and modifying processes, products, documents, and workflows within a company. Change management ensures that any alterations made to the quality processes are carefully evaluated to minimize risks and maximize benefits.

Change management is an essential component of a QMS as it enables companies to adapt to evolving regulatory and customer requirements while safeguarding quality and compliance.

Training Management

Training management ensures that employees possess the necessary skills and knowledge to perform their jobs effectively and contribute to achieving quality objectives.

By providing comprehensive training programs, companies ensure employees understand their roles, responsibilities, and requirements of a QMS. Training management helps to minimize errors and improve productivity.

Deviation and Nonconformance Management

Deviation and nonconformance management is the systematic process of identifying, documenting, investigating, resolving, and preventing deviations or nonconformances related to procedures, products, suppliers, etc.

For example, a supplier delivered fewer items than expected, or equipment calibration is overdue.

Deviation and nonconformance management ensure product quality, patient safety, and regulatory compliance. When deviations or nonconformities occur, it is essential to address them promptly and effectively to prevent recurrence, minimize the impact on product quality and safety, and ensure continuous improvements.

Complaint Management

Complaint management is the formal process for receiving, recording, investigating, and resolving customer complaints. Complaint management enables companies to respond effectively to customer feedback, address quality issues, and drive continuous improvement.

By prioritizing customer satisfaction and actively engaging with customer complaints, companies can build trust, loyalty, and long-term relationships with their customers while maintaining compliance with regulatory requirements.

CAPA Management

Corrective Action and Preventive Action (CAPA) management establishes a formal process for identifying, investigating, and addressing problems and preventing the occurrence of similar issues.

CAPA management helps with identifying, addressing, and preventing non-conformities and deviations. By implementing effective CAPA processes, companies can minimize risks, improve processes, and ensure continuous improvement.

Equipment Management

Equipment management involves the registration, qualification, calibration, maintenance, and disposal of equipment used in the manufacture of products.

Equipment management focuses on establishing a systematic approach to ensuring the ongoing functionality, accuracy, and reliability of all equipment used within the companies’ processes. Properly managed equipment ensures that manufacturing processes are conducted accurately and consistently, minimizing the risk of defects or deviations from quality specifications.

Supplier Management

Supplier management involves the evaluation, selection, and monitoring of suppliers to ensure that they consistently deliver uniform and high-quality products or services.

Effective supplier management helps companies identify reliable and capable suppliers, optimize supply chain performance, and mitigate risks associated with poor supplier performance.

Risk Management

Risk management involves the identification, assessment, mitigation, and monitoring of risks that could impact product quality, safety, or compliance with regulatory requirements.

By proactively identifying and assessing risks, companies can implement strategies to mitigate or eliminate risks, thereby reducing the likelihood of quality incidents like nonconformance and deviations.

Audit and Inspection Management

Audit and inspection management is the systematic planning, execution, and follow-up of audits and inspections to assess compliance with internal policies, procedures, quality standards, industry guidelines, and regulatory requirements.

Audit and inspection management provides assurance that quality management processes are effectively implemented and followed throughout the company.

What is the Quality Management System (QMS) Documentation Structure?

Quality Management System documentation is the Quality Manual that defines a company’s quality system. QMS documentation includes policies, procedures, work instructions, records, and other relevant documents.

QMS documentation structure is a hierarchical organization of documents. The document hierarchy facilitates comprehension, communication, and visualization of the documentation structure.

The four levels of documents in a QMS pyramid are described below.

• Quality Policy: The quality policy is a high-level statement outlining a company’s commitment to quality. The quality policy sets the overall direction for quality efforts and serves as a guiding principle for employees.

• Procedures: Procedures outline the step-by-step methods or processes for performing specific tasks or activities. Procedures serve to standardize operations, ensure consistency, and facilitate compliance with regulatory requirements.

• Work Instructions: Work instructions provide detailed guidelines for completing specific tasks or operations, often at a more granular level than procedures. Work instructions are used to ensure that tasks are performed correctly, safely, and efficiently.

• Records: Records document the results, activities, or events related to quality management processes, such as audits and training. Records serve as evidence of performance and compliance, enabling traceability and accountability.

What is Quality Management Software?

Quality management software is a digital platform designed to streamline and automate quality management processes within a company.

Quality management software is used to streamline and automate quality management processes and help ensure compliance with standards, guidelines, and regulations. QMS software enables the systematic control of quality policies, procedures, and documentation, facilitating compliance with applicable requirements.

Adopting quality management software enables companies to implement an electronic QMS (eQMS), often referring to the software itself. Electronic QMS streamlines processes, including document control, change management, training management, audit management, nonconformance and deviation management, CAPA management, supplier management, and others.

Who is Quality Management System Software For?

Quality management system software is designed for all companies seeking to streamline and automate quality management processes, improve efficiency, and ensure compliance with regulatory and customer requirements.

QMS software is particularly valuable for highly regulated industries, such as Life Sciences, where compliance with specific regulations, standards, and guidelines is essential for operational success and patient safety.

SimplerQMS provides electronic QMS tailored specifically for Life Science companies. Our QMS software is designed to address the complex quality management needs in the pharmaceuticals, biotechnology, medical devices, CRO, CDMO, and other Life Science industries.

What are the Benefits of Using Electronic QMS?

The main benefits of using QMS software are listed below.

• Improved Compliance: QMS software helps companies comply with regulatory and customer requirements. The software’s predefined workflows ensure processes are being correctly followed. All actions in the workflow are automatically documented in a time-stamped audit trail.

• Enhanced Efficiency: Quality management software automates and streamlines quality management processes, reducing manual effort and minimizing errors. The implementation of QMS software leads to increased productivity and operational efficiency within the company.

• Increased Transparency: QMS software provides real-time visibility into quality management activities, allowing employees to access relevant data. Transparency fosters accountability, facilitates collaboration, and promotes informed decision-making.

• Cost Savings: QMS software reduces the need for manual paperwork, streamlines processes, and helps prevent non-value-adding tasks. As a result, companies can achieve cost savings through improved efficiency, reduced waste, and decreased risk of noncompliance.

We designed a QMS software business case template to assist you in assessing the value of implementing a modern QMS software solution and presenting it to your management.

The template is tailored to help you visualize the specific benefits that cloud-based QMS software can bring to your business, including potential efficiency enhancements, cost reductions, and improvements in compliance.

Assess the benefits of investing in an eQMS solution for your company by downloading our QMS Software Business Case template.

What Benefits Cloud-Based QMS Offers Compared to an On-Premise Solution?

The main benefits that cloud-based QMS software offers when compared to an on-premise QMS solution are listed below.

• Work From Anywhere: A cloud-based QMS stores data centrally and is accessible from anywhere with an internet connection. The cloud-based solution allows employees to work remotely, improving flexibility and collaboration.

• Improved Security: Most web-based QMS solutions offer robust security measures, including encryption, access controls, and data backups, ensuring the protection of sensitive information.

• Reduced Costs: Cloud-based QMS eliminates the need for on-premises infrastructure, reducing hardware, maintenance, and IT support costs associated with traditional on-premise QMS software systems.

• Automatic Software Updates: Cloud-based QMS providers handle software updates and maintenance, ensuring that users always have access to the latest features and security patches without the need for manual intervention.

• Faster Implementation: Online cloud-based QMS solutions can be deployed quickly, often requiring minimal setup and configuration, allowing companies to start using the system promptly.

• Scalability: Cloud-based QMS software offers scalability to accommodate the changing needs of companies, allowing for seamless expansion or downsizing of users, storage, and capabilities as business requirements evolve.

Cloud-based QMS solutions offer greater flexibility, scalability, and accessibility, along with improved security and cost-effectiveness. Companies are no longer limited to on-premise QMS software solutions and can now leverage the benefits of cloud-based QMS software.

When is the Right Time to Consider a QMS Software?

QMS software can be considered at any time, even when starting a company. Implementing QMS software from the beginning saves time and effort as it establishes robust quality management processes early on.

Companies often implement an eQMS once they have established or are actively developing their quality management system and related documentation. Although there is no perfect timing for implementation, the earlier a company implements an eQMS, the greater the benefits it can gain.

Some situations and challenges indicate the necessity for companies to adopt an eQMS. These include the need to enhance communication, automate QMS processes, improve compliance efforts, improve visibility into quality data, pursue scalability, and more.

How to Choose a Quality Management Software?

The main steps to choosing quality management software are mentioned below.

 

1. Assess Your Requirements: Evaluate the company’s quality management needs and objectives, considering factors such as regulatory compliance requirements and process requirements.
2. Research and Compare QMS Software Vendors: Research multiple QMS software vendors, comparing features, pricing, customer reviews, and industry reputation to identify potential candidates.
3. Select Relevant QMS Software Vendors: Pick out QMS software vendors whose offerings align closely with the company’s requirements and objectives, ensuring vendors have a proven track record in the industry.
4. Get Demos and Have Meetings: Request demonstrations and schedule meetings with selected vendors to gain a deeper understanding of their software’s capabilities and how it can address specific needs.
5. Consider Getting a Trial: Explore the possibility of obtaining a trial period from the vendors under consideration, allowing employees to test the software in a real-world setting.
6. Shortlist QMS Software Vendors: Create a shortlist of the most promising QMS software vendors based on their presentations, feedback from demos, and alignment with the company’s needs.
7. Get Demonstration of Specific Use Cases: Ask shortlisted vendors to provide demonstrations focused on specific use cases relevant to the company, ensuring their software can effectively address particular challenges.
8. Negotiate With Shortlisted QMS Providers: Engage in negotiations with the shortlisted QMS providers to discuss pricing, licensing terms, support services, any other add-ons, and any customization options required.
9. Make Final Decision: Make a final decision based on a comprehensive evaluation of each vendor’s offerings, taking into account factors such as functionality, cost-effectiveness, vendor support, and potential for long-term value.

Simplify the decision-making process of choosing a QMS software with our QMS Software Comparison Template.

Use the template to conduct a thorough comparison of various QMS software solutions, evaluating vendor features, functionalities, pricing structures, and more. The comprehensive side-by-side comparison helps you understand exactly what each QMS software and vendor has to offer.

Ready to Learn More?

To learn how your life science company can make the most of SimplerQMS’s QMS solution, book a free demo.

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