The cGMPs are enforced by the Food and Drug Administration (FDA) and apply to companies operating in the United States.

They apply to a wide range of products, including drugs, biologics, medical devices, food, and dietary supplements. The specific requirements of cGMPs vary depending on the type of product.

In this article, we will discuss the importance and objectives of cGMPs, key requirements and areas, and how to maintain compliance with cGMPs. We will also discuss the role of QMS software in supporting cGMP compliance.

SimplerQMS provides QMS software or eQMS that supports compliance with cGMP regulations. We offer a system designed specifically for Life Science companies. To learn more about our QMS software, book a demo and talk with our quality experts.

The following topics are covered in greater detail in this article:

• What is cGMP?
• What Are the Key cGMP Requirements?
• What Are the Key Areas of cGMP?
• How to Maintain cGMP Compliance?
• What Is the Role of QMS Software in cGMP Compliance?

What is cGMP?

CGMP full form stands for “Current Good Manufacturing Practice.”

CGMP refers to the set of regulations established by the United States Food and Drug Administration (FDA).

The cGMP regulations contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a product.

CGMP applies to the pharmaceutical, food and beverage, medical devices, and dietary supplement industries. The meaning of cGMP lies in its role in maintaining the safety, efficacy, and quality of products throughout their manufacturing process within these sectors.

What Is the Importance of cGMP?

The importance of cGMP lies in ensuring the consistent quality, safety, and efficacy of products in FDA-regulated industries.

By complying with cGMP regulations, companies can maintain uniform and high-quality manufacturing processes, reduce the risk of product defects or contamination, and meet regulatory and customer requirements.

What Is the Objective of cGMP?

The objective of cGMP is to establish a robust framework that governs every aspect of the manufacturing process, from raw materials to final product distribution, to deliver safe and effective products to consumers.

What Is the Difference Between GMP and cGMP?

The difference between GMP and cGMP is the market they apply to and the level of current practices.

Good Manufacturing Practices (GMP) is a set of requirements applied in various industries, including pharmaceutical manufacturing, to ensure products meet their quality standards.

On the other hand, current Good Manufacturing Practices (cGMP) is a specific set of regulations outlined by the FDA for industries operating within the United States. Accordingly, the “C” in cGMP, which stands for “current,” requires companies to use technologies and systems that are up-to-date to comply with the regulations.

Other differences between GMP and cGMP include quality, cost, and standards, as demonstrated in the illustration below.

Quality

Quality is at the core of both GMP and cGMP requirements, ensuring safe, uniform, and high-quality products.

GMP entails adhering to the required industry standards, while cGMP takes an extra step by keeping up with the latest technologies to ensure updated practices.

Cost

Cost is an inherent consideration in both GMP and cGMP compliance.

However, cGMP tends to be more expensive due to the necessity of additional testing and investments in state-of-the-art technologies to meet the latest standards and requirements.

Current Standard

GMP represents the minimum requirements for product manufacturing, whereas cGMP signifies the advanced and up-to-date regulations that apply to the industry.

Now that we have a clear understanding of what cGMP entails, let’s examine its key requirements to ensure quality and compliance in the manufacturing process.

What Are the Key cGMP Requirements?

The cGMP requirements differ based on the type of product they govern.

Below are the key cGMP requirements applicable to some of the larger Life Science industries.

21 CFR Part 111

The 21 CFR Part 111 regulation outlines cGMP requirements specific to the manufacturing, packaging, labeling, and holding operations for dietary supplements.

It covers all aspects of the manufacturing, packaging, labeling, and holding of dietary supplements, including the facilities, equipment, personnel, and procedures used.

The aim is to ensure dietary supplements’ quality, purity, and safety throughout their production and distribution.

21 CFR Part 210

The cGMP requirements for the general manufacturing, processing, packing, and holding of drugs are established in the 21 CFR Part 210 regulation.

It encompasses various aspects of drug production, such as equipment, personnel, and procedures, to ensure consistent product quality and safety.

21 CFR Part 211

The 21 CFR Part 211 specifies cGMP requirements for finished pharmaceutical products.

It covers all stages of pharmaceutical manufacturing, from raw materials to the final packaged products, to guarantee their safety, identity, strength, quality, and purity.

Many Pharma companies operating in the US implement a pharmaceutical quality management system that complies with drug-specific cGMPs, such as 21 CFR Part 211.

21 CFR Part 212

The 21 CFR Part 212 regulation provides cGMP requirements specifically for Positron Emission Tomography (PET) drugs.

It ensures the safe and accurate manufacturing of PET drugs, which are radiopharmaceuticals used in medical imaging.

21 CFR Part 225

cGMP for drugs used in medicated feeds for animal health are outlined in the 21 CFR Part 225 regulation.

It ensures that drugs added to animal food are manufactured, processed, and labeled properly to meet safety and efficacy requirements.

21 CFR Part 606

The 21 CFR Part 606 establishes the cGMP for blood and blood components used in transfusions and medical treatments.

The regulation covers the facilities, equipment, personnel, and procedures used to collect, store, and distribute blood and blood components. It focuses on ensuring the safety and quality of blood products to protect recipients’ health.

21 CFR Part 820

The 21 CFR Part 820, also known as the Quality System Regulation (QSR), sets forth cGMP requirements for medical device manufacturers.

It encompasses various quality management aspects, from design and production to distribution, to ensure safe and effective medical devices. You can learn more about this part of regulation in a dedicated article about 21 CFR Part 820 quality management systems.

For more information on medical device QMS systems, check out our article on Medical Device QMS.

Recognizing the shared key areas of cGMP regulations is essential. However, companies must also grasp the specific requirements pertinent to their operations to develop appropriate processes and controls.

What Are the Key Areas of cGMP?

The areas of cGMP cover various aspects of the manufacturing process to ensure product quality, safety, and efficacy.

Some of the key cGMP areas along with some examples of how SimplerQMS can help manage them are described in more detail below.

Production and Process Controls

This area covers the critical processes involved in manufacturing, including the use of approved procedures, batch records, process validation, and others. Strict controls ensure consistency and reproducibility of product quality.

For instance, to comply with cGMP, companies should maintain detailed batch records with clear documentation of each step taken during production, including critical control points and product sampling.

Written Procedures for Deviations and Nonconformances

Establishing written procedures for handling deviations and nonconformances is essential to address unexpected events or situations that may lead to cGMP noncompliance.

Clear and documented procedures enable companies to investigate deviations and nonconformances thoroughly, determine their root causes, and take appropriate corrective actions.

You can learn more about deviations in the pharmaceutical industry with our dedicated article on deviation management in pharma.

With SimplerQMS, managing deviations or nonconformances (NCs) is an easy task. You can record a deviation or an NC, relate relevant documents to ensure the traceability of information, and directly escalate the issues to Corrective and Preventive Action (CAPA) if needed. The system notifies assigned users of required actions, ensuring timely task completion.

Organization and Personnel

This area focuses on establishing clear roles and responsibilities within the company and ensuring that personnel are appropriately trained and qualified to perform their tasks.

Employees involved in manufacturing, processing, packing, and holding, among many processes, must wear clean and suitable clothing. They should also use protective apparel, for example, head, face, hand, and arm coverings, whenever needed to prevent product contamination.

An example of cGMP for personnel is developing a training plan and conducting regular training sessions to ensure employees understand applicable cGMP requirements, standard operating procedures (SOPs), and safety protocols related to their tasks and responsibilities.

QMS software like SimplerQMS simplifies the creation of training plans, scheduling training assignments, and assigning the appropriate users to training. The system helps ensure timely training completion by sending automated notifications and reminders about the assignment.

Buildings and Facilities

cGMP regulations require that manufacturing facilities are designed, constructed, and maintained to meet specific cleanliness and safety requirements.

Proper facility design and maintenance help prevent contamination and ensure a hygienic environment for production. This includes cleaning and sanitizing all surfaces regularly, among other procedures.

For example, companies can conduct a risk assessment to identify potential sources of contamination and develop a more comprehensive cleaning and sanitation plan.

Equipment

The regulations emphasize the importance of using well-maintained and calibrated equipment to ensure accurate and reliable results during manufacturing. Proper equipment maintenance reduces the risk of product defects and deviations.

An example of equipment cGMP includes selecting equipment that is made from materials that are compatible with the materials that will be used in the manufacturing process.

SimplerQMS streamlines equipment management by facilitating the creation of calibration and maintenance plans. Our solution sends automatic notifications and reminders to responsible people to perform their assignments on time, helping ensure that equipment is always in good working order.

Records and Reports

Accurate and comprehensive recordkeeping is essential in cGMP compliance. Companies are required to maintain detailed records with evidence of all manufacturing and quality control activities to demonstrate compliance with regulations.

An example of cGMP could be a well-implemented and robust document management system that controls versions of SOPs, batch records, and other cGMP-process-related documents.

Implementing a QMS that reflects cGMP requirements in the key areas is essential for maintaining compliance throughout the manufacturing process.

With SimplerQMS, it is easy to keep track of document versions. The software automatically creates new versions of documents, along with a time-stamped audit trail for every change that shows the document version, and the responsible person for the change, date, and time.

How to Maintain cGMP Compliance?

Maintaining cGMP compliance requires management commitment and following activities as specified in the applicable requirements.

By following the key actions below, companies can ensure continuous compliance with cGMP requirements.

• Internal audits: Companies should conduct regular internal audits to assess compliance with cGMP requirements and identify potential areas of noncompliance. Internal audits should be conducted by a competent team to review processes, procedures, and systems. The audit findings should be documented, and deviations must be addressed with corrective and preventive actions (CAPAs) to prevent recurrence, if necessary.
• Ongoing training: Continuous training must be provided for employees to ensure they are well-informed about cGMP regulations, SOPs, and best practices. Properly trained staff are more likely to follow procedures accurately, reducing the risk of errors. Regular training sessions keep employees updated on any changes to regulations.
• Maintaining effective documentation: Critical processes, data, and quality-related activities must be documented appropriately and retained securely. Proper documentation includes batch records, SOPs, calibration records, validation reports, and other cGMP-related documents. Well-maintained records provide evidence of compliance during inspections and help identify deviations or trends for continuous improvement.
• Maintaining equipment in good condition: Equipment used in manufacturing, testing, and quality control processes must be well-maintained and calibrated to ensure accurate and reliable results. Implementing preventive maintenance plans prevents unexpected equipment failures, helps extend the lifespan of the equipment, and minimizes the risk of cGMP deviations due to equipment-related issues.
• Perform periodic reviews: Companies should schedule routine reviews to evaluate the adequate functioning of processes and procedures in compliance with cGMP requirements. Reviews include a comprehensive assessment of process execution. Findings from these reviews must be documented, enabling informed decision-making and continuous improvement.

These actions help maintain compliance with cGMP by organizing a system that effectively manages cGMP-related processes. Additionally, implementing QMS software can streamline quality processes and further support cGMP compliance.

What Is the Role of QMS Software in cGMP Compliance?

QMS software supports Life Science companies in achieving and maintaining cGMP compliance by automating tasks, facilitating employee training, and helping identify areas of improvement, among many other things.

SimplerQMS provides an eQMS software solution designed to support cGMP compliance.

Although cGMP processes can be managed manually using paper-based or hybrid systems, these can lack document and record control, be time-consuming, and error-prone.

An improved approach involves the implementation of eQMS software with pre-defined workflows tailored to life science industries, guiding users through the intricacies of diverse QMS processes and facilitating adherence to regulatory requirements.

Here are some examples of key process areas, along with how SimplerQMS software helps ensure cGMP compliance for each one:

• Document Control: Our eQMS provides pre-defined workflows that guide users through actions like document reviews and approvals with electronic signatures, ensuring appropriate action is taken. It also tracks all document changes and versions, along with time-stamped audit trails.
• Change Control: SimplerQMS helps Life Science companies create, document, and manage all changes. We provide a centralized platform for managing change requests, tracking the status of changes, and ensuring that all changes are reviewed and approved before they are implemented.
• Training Management: Our software simplifies employee training while supporting compliance with Life Science requirements. SimplerQMS streamlines learning processes by automating assignments, reminders, and status tracking, as well as helping ensure that everyone is trained on the latest procedures.
• Equipment Management: SimplerQMS simplifies equipment registration, calibration, and maintenance tasks. Our system allows you to categorize and monitor equipment and set up task schedules with automated notifications and reminders.

Documentation in SimplerQMS is securely signed using 21 CFR Part 11-compliant electronic signatures to promote accountability within these and more processes.

Apart from the processes mentioned above, the SimplerQMS solution supports other QMS processes that include CAPA management, customer complaint management, audit management, supplier management, and more.

By providing such QMS process support, the SimplerQMS platform supports compliance with cGMP and several other Life Science requirements, which include ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, EU GMP Annex 11, EU GMP, and more. By providing QMS process support, SimplerQMS software helps companies comply with regulatory requirements.

If you are considering implementing an eQMS solution in your company, we have a free eQMS Business Case template for you to download.

The template will assist you in calculating the economic value and time saving that an eQMS can bring, enabling you to effectively present your findings to management.

Final Thoughts

CGMP, or “Current Good Manufacturing Practices,” are regulations established by the FDA to ensure consistent production and control of products in industries like pharmaceuticals, food and beverage, medical devices, and dietary supplements.

Some companies use paper-based or hybrid systems to manage cGMP processes. However, these can be time-consuming and prone to errors.

A better solution is using eQMS software, like SimplerQMS, which provides comprehensive QMS process support. Our pre-defined workflows guide users through processes to ensure the completion of tasks in an orderly manner facilitating adherence to regulatory requirements.

SimplerQMS provides eQMS software specifically designed to support cGMP compliance and several other Life Science requirements, such as ISO 9001:2015, FDA 21 CFR Part 11, FDA 21 CFR Part 211, FDA 21 CFR Part 212, EU GMP Volume 4 Annex 11, EU GMP Volume 4 Part I, and more.

If you are interested in learning more about our eQMS software, you can book a free demo and talk to our Quality Solution consultants.

The post What are Current Good Manufacturing Practices (cGMP)? appeared first on SimplerQMS.

Understanding these differences is essential for Life Science companies operating in both the American and European markets to ensure compliance and avoid potential nonconformances.

This article will discuss the key differences between 21 CFR Part 11 and EU Annex 11. We will explain what each entails, their requirements, and their differences. We will also show how SimplerQMS can help you achieve compliance with both.

Life Science companies are increasingly adopting electronic systems to manage regulated processes. These systems provide technology to streamline and automate processes, reducing risks and improving efficiency.

These electronic systems also help companies comply with several requirements, such as FDA 21 CFR Part 11 and EU GMP Annex 11.

SimplerQMS provides eQMS software designed for Life Science companies and complies with 21 CFR Part 11 and EU GMP Annex 11. Book a demo and talk to our quality experts today to get a more comprehensive understanding of the QMS software.

This article covers the following topics in more detail:

• What Is the FDA 21 CFR Part 11?
• What Is EU GMP Annex 11?
• What Are the Key Differences Between 21 CFR Part 11 and Annex 11?
• How SimplerQMS Supports Your Compliance With 21 CFR Part 11 & EU Annex 11

What Is the FDA 21 CFR Part 11?

The 21 CFR Part 11 is a part of the Food and Drug Administration (FDA) regulation that establishes criteria for using electronic records and signatures.

The scope of 21 CFR Part 11 encompasses electronic records created, modified, maintained, archived, retrieved, or transmitted under FDA requirements.

The regulation applies to any Life Science companies that utilize electronic systems for recordkeeping and signature processes subject to FDA regulations within the United States. This includes pharmaceutical manufacturers, contract research organizations (CROs), biotechnology companies, and medical device manufacturers, among others.

Its primary purpose is to ensure the integrity, authenticity, and reliability of electronic records and signatures used in FDA-regulated activities by setting forth comprehensive requirements.

What Are the Key Requirements of the FDA 21 CFR Part 11?

FDA 21 CFR Part 11 specifies the requirements for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records and signatures on paper.

Here, we will provide a concise overview of the sections of 21 CFR Part 11 and emphasize its key requirements. If you are interested in gaining a more thorough understanding of the various parts and specific requirements of 21 CFR Part 11, we recommend reading our comprehensive article on 21 CFR Part 11 requirements.

Electronic Records Requirements

Companies must follow specific procedures and controls to maintain the records’ authenticity, integrity, and, if needed, confidentiality.

Some of the required procedures and controls for compliant electronic records include the following:

• 21 CFR 11.10: Controls for closed systems ensure system validation, record retrieval, system access controls, audit trails, operational checks, user training, and more.
• 21 CFR 11.30: Controls for open systems include the exact requirements as closed systems, with added security measures, such as document encryption and appropriate digital signature standards.
• 21 CFR 11.50: Signature manifestations, such as the printed name of the signer, date, time, and meaning of signature, should be included in the electronic records.
• 21 CFR 11.70: Electronic signatures should be linked to their respective records to prevent falsification.

Electronic Signatures Requirements

To be valid and legally binding, electronic signatures must meet specific procedures and controls. These requirements help to ensure that the signer is who they say they are, that the signature is not tampered with, and that the document is genuine.

Here are some of the requirements for electronic signatures:

• 21 CFR 11.100: General requirements include requirements for electronic signatures to be unique and have their user identity verified.
• 21 CFR 11.200: Electronic signature components and controls specify using at least two distinct identification components, such as identification code and password, controls for sequence signing, and more.
• 21 CFR 11.300: Controls for identification codes and passwords ensure the uniqueness of combined identification codes and passwords, loss management procedures, and transaction safeguards, among other requirements.

What Is EU GMP Annex 11?

The EU GMP Annex 11 is a guideline the European Union (EU) issued regarding using computerized systems in good manufacturing practices (GMP) for human and veterinary medicinal products.

The guideline outlines requirements for implementing and validating computerized systems to ensure data integrity, accuracy, and security in GMP-related activities.

It applies to all companies operating within the European Union in the manufacture of medical products with GMP-regulated activities, including pharmaceutical, contract manufacturing organizations (CMO), and others.

The purpose of EU Annex 11 is to provide guidance for interpreting the principles and guidelines of computerized systems. It helps medicinal product manufacturers assess and implement necessary controls to minimize risks and identify vulnerabilities.

What Are the Key Requirements of EU GMP Annex 11?

Compliance with EU GMP Annex 11 is essential for companies who want to ensure that their computerized systems are used in a way that meets regulatory requirements in GMP-regulated activities.

Below, we provide a brief explanation of the key requirements of EU Annex 11. However, please note that this is not an exhaustive list. For a more comprehensive understanding of EU Annex 11, we recommend reading our dedicated article on EU Annex 11 requirements.

General Requirements

• Risk Management: The risks associated with computerized systems should be assessed, and companies should implement controls to mitigate those risks.
• Personnel: All personnel who use computerized systems must have the appropriate training and qualifications to perform their tasks.
• Suppliers and Service Providers: Formal agreements should be in place with third-party suppliers and service providers that clearly define their responsibilities.

Project Phase

• Validation: Companies should have a validation plan that covers the relevant steps of the lifecycle of the computerized system. The validation plan should be based on the risk assessment and justify the standards, protocols, acceptance criteria, procedures, and records used.

Operational Phase

• Data Storage: Stored data must be secure and checked for accessibility, readability, and accuracy. Access to data needs to be ensured throughout the retention period.
• Printouts: Printed copies of electronically stored data must be available and indicate if any data has been changed since the original entry.
• Audit Trails: The reason for any change or deletion of GMP-relevant data should be documented. Audit trails should be available in a comprehensible form and regularly reviewed.
• Electronic Signature: Electronic signatures need to be equivalent to their handwritten counterparts. Records must include the time and date that they were signed and have the signatures permanently linked to them.

What Are the Key Differences Between 21 CFR Part 11 and Annex 11?

21 CFR Part 11 and EU Annex 11 have different scopes and requirements. However, they both are important frameworks for ensuring the quality and integrity of data in electronic records.

It is essential to understand the differences between the two frameworks to comply with the requirements that apply to your specific needs.

Overall, 21 CFR Part 11 is more specific and detailed in its requirements than EU Annex 11. 21 CFR Part 11 outlines specific requirements that must be met, while EU Annex 11 provides general guidance to the areas of compliance.

When comparing these frameworks, several aspects are considered. These encompass the following elements.

Definition

The FDA 21 CFR Part 11 regulatory framework outlines the criteria governing electronic records and signatures. It is a comprehensive set of requirements for ensuring electronic documentation’s integrity, authenticity, and reliability within FDA-regulated industries.

On the other hand, the EU Annex 11 is a guideline that provides general principles for computerized systems used in Good Manufacturing Practice (GMP) activities.

Market

Another difference between 21 CFR Part 11 and EU Annex 11 is their geographical applicability.

21 CFR Part 11 applies to companies operating in the United States market under FDA regulations.

In contrast, EU Annex 11 applies to companies operating in the European Union market and conducting GMP activities according to EU guidelines.

Scope

The difference in the scope of the frameworks is that 21 CFR Part 11 focuses on electronic records and signatures in open and closed computer systems used in FDA-regulated activities, ensuring their integrity, authenticity, and reliability.

EU Annex 11 addresses computerized systems used in GMP-regulated activities, providing appropriate implementation and management guidelines.

While 21 CFR Part 11 specifically targets electronic records and signatures, EU Annex 11 takes a broader approach by encompassing the whole computerized system.

Regulatory Authority

Another difference lies in the regulatory authorities overseeing the frameworks.

21 CFR Part 11 is regulated by the Food and Drug Administration (FDA) in the United States. While EU Annex 11 is regulated by the European Medicines Agency (EMA) in the European Union.

Regulatory Status

There is a significant difference between the regulatory status of the frameworks.

21 CFR Part 11 is a regulation and requires mandatory compliance when utilizing electronic records and signatures. It carries legal weight and enforceability, meaning companies operating under FDA regulations must comply with the 21 CFR Part 11 requirements.

On the contrary, EU Annex 11 is a guideline that offers recommendations and guidance for interpreting the GMP principles. It is not legally binding, meaning companies operating within the European Union market are not obligated to have compliance.

Audit Trails

The framework requirements for audit trails differ on the records they apply to.

In 21 CFR Part 11, audit trails are required for all electronic records, encompassing a broader range of data.

On the other hand, in EU Annex 11, audit trails are specific for GMP-relevant data.

This difference indicates that 21 CFR Part 11 places a bigger emphasis on the comprehensive audit trail implementation. Meanwhile, EU Annex 11 narrows its focus to GMP-specific data.

Risk Management

While 21 CFR Part 11 does not explicitly mandate a risk assessment, EU Annex 11 specifies that a risk assessment should be conducted throughout the lifecycle of the computerized system.

The risk assessment in EU Annex 11 encompasses patient safety, data integrity, and product quality considerations.

The difference indicates that EU Annex 11 emphasizes the proactive identification and management of risks associated with computerized systems. However, 21 CFR Part 11 does not explicitly require a formal risk assessment process.

The infographic below illustrates these main differences between the 21 CFR Part 11 and EU Annex 11.

When it comes to managing regulated activities, many Life science companies are adopting electronic Quality Management Systems (eQMS) compliant with 21 CFR Part 11 and EU Annex 11.

Such eQMS solutions provide a comprehensive and streamlined approach to managing quality management processes while helping ensure compliance.

How SimplerQMS Supports Your Compliance With 21 CFR Part 11 & EU Annex 11

SimplerQMS offers an eQMS software solution compliant with FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.

Here are some of SimplerQMS’s key capabilities that help achieve compliance with 21 CFR Part 11 and EU Annex 11.

System Validation

SimplerQMS is fully validated according to ISPE GAMP5, a risk-based approach to computerized systems.

The system is tested and continuously validated to meet 21 CFR Part 11 and EU Annex 11 requirements. We handle all system validation activities. There are no additional expenses, resources, or time commitments to software validation from our customers.

Data Storage and Retrieval

Our cloud-based system enables easy access to documents from anywhere at any time.

Records are securely stored, ensuring availability for inspection throughout the retention period. A search feature simplifies record retrieval by keyword search in document titles and content.

Personnel Training

We provide comprehensive training to individuals on how to use our system. We offer unlimited training sessions, workshops, written material, and videos to facilitate learning.

Our integrated Training Management module also streamlines training management in your organization by allowing the easy creation of training plans, assignments, progress monitoring, and automated notifications.

Record Generation

SimplerQMS simplifies record generation by providing document templates.

We support copying and exporting records for audits and regulatory inspection, including printable documents. Our controlled printing capability ensures tracking of printout status.

Audit Trails

SimplerQMS provides computer-generated and time-stamped audit trails, automatically storing each record version.

The audit trail is a chronological history of all actions performed to a record that includes the user, date, time, and actions taken.

Electronic Signatures

We provide EU Annex 11 and 21 CFR Part 11 compliant electronic signature capabilities.

In SimplerQMS, electronic signing is only possible one record at a time, with all signature components, that includes the signer’s name, date, time, and meaning of the signature.

Each signing credential is unique and linked to the corresponding record, ensuring integrity and preventing falsification.

System Access Control

SimplerQMS integrates with Microsoft Entra ID (previously known as Microsoft Azure Active Directory) for secure identity and access management.

Access to the system and specific records is limited only to authorized personnel. Users are assigned unique identification codes and passwords to ensure secure access, safeguarding the confidentiality of electronic records.

SimplerQMS offers more than 21 CFR Part 11 and EU Annex 11 compliance. We help companies comply with several Life Science requirements, such as 21 CFR Part 211, 212, and 820, ISO 13485:2016, ISO 9001:2015, MDR and IVDR, EU volume 4 GMP, ICH Q10, and more.

Our comprehensive QMS software solution includes various QMS modules – document management, change control, employee training, customer complaint, CAPA management, supplier management, deviation management, and more.

If you are considering implementing an eQMS solution in your company, download our free eQMS Business Case template.

This template will help you calculate the real economic benefits and time savings of an eQMS and present your finding to management.

Final Thoughts

21 CFR Part 11 and Eu Annex 11 differ regarding their scope, applicability, and requirements.

While 21 CFR Part 11 is a US regulation governing electronic records and signatures in all FDA-regulated activities. EU Annex 11 is an EU guideline for the computerized systems in GMP-regulated activities for medicinal products.

Life Science companies are increasingly implementing electronic systems such as eQMS software to manage quality processes and improve compliance efforts.

SimplerQMS provides a tailored eQMS for Life Science companies to streamline their quality processes and help achieve compliance.

Experience firsthand how SimplerQMS can assist you in streamlining your QMS processes and achieving compliance with Life Science requirements. Schedule a personalized demo with our knowledgeable eQMS system experts today.

The post FDA 21 CFR Part 11 vs EU Annex 11: What is the Difference? appeared first on SimplerQMS.

ICH Q10 provides a comprehensive model based on the International Standards Organization (ISO) quality concepts. It also incorporates relevant Good Manufacturing Practice (GMP) regulations.

The purpose of the guideline is to ensure the establishment of robust quality systems that support the consistent production of safe and effective pharmaceutical products.

This article provides an overview of the ICH Q10 Pharmaceutical Quality System, highlighting its importance and Quality Management System model. We also explore the role of eQMS software in implementing and maintaining the QMS that aligns with ICH Q10 principles.

There is a growing trend of Life Science companies adopting digital QMS solutions. These solutions provide an efficient and streamlined approach to managing quality processes.

SimplerQMS offers QMS software suited for pharmaceutical companies seeking to implement the ICH Q10 Quality Management System model. Schedule a personalized demo and talk to our experts to discover how SimplerQMS can streamline your company’s quality processes and help you work more efficiently.

Here is what we will discuss in this article:

• What Is the ICH Q10 Quality Management System?
• Why Is ICH Q10 Quality Management System Important?
• ICH Q10 Pharmaceutical Quality System Model
• Role of Pharmaceutical eQMS Software
• Frequently Asked Questions

What Is the ICH Q10 Quality Management System?

The ICH Q10 Quality Management System is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.

It is established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

ICH Q10 applies to systems supporting the production of drug substances and drug products, including biotechnology and biological products, throughout their entire lifecycle.

These systems control essential processes such as formulation development, drug manufacturing, retention of documentation, quality control, change management system, CAPA system, and more.

Life Science companies adopting ICH Q10 are among others pharmaceuticals and biotechnological manufacturers, and contract research organizations (CROs).

ICH Q10 is part of the tripartite guideline that includes ICH Q8 and ICH Q9.

These guidelines collectively cover different aspects of product development and manufacturing in the pharmaceutical industry.

Let’s explore what each guideline, ICH Q8, Q9, and Q10, covers:

• ICH Q8 (Pharmaceutical Development): This guideline provides guidance on applying scientific approaches and quality risk management during the development and manufacturing of pharmaceutical products.
• ICH Q9 (Quality Risk Management): This guideline focuses on systematic approaches to quality risk management, ensuring that companies address potential risks effectively in their operations.
• ICH Q10 (Pharmaceutical Quality System): This guideline provides a model for the quality management system in the pharmaceutical industry, ensuring consistent quality throughout the product lifecycle.

ICH Q10 is built upon the foundation of regional Good Manufacturing Practice (GMP) requirements and is intended to be used in conjunction with them.

SimplerQMS provides efficient QMS software for pharmaceutical companies with integrated quality management processes. It helps ensure compliance with the ICH Q10 guideline, GMP requirements, FDA regulations, ISO standards, and more.

Why Is ICH Q10 Quality Management System Important?

The ICH Q10 Quality Management System is important because it provides a structured framework for pharmaceutical companies to establish and maintain a culture of quality.

This framework helps companies to ensure compliance with regulatory requirements, mitigate risks, and continually improve their processes and products.

ICH Q10 Pharmaceutical Quality System Model

ICH Q10 Pharmaceutical Quality System Model provides guidelines and principles for establishing, implementing, and maintaining a quality management system in the pharmaceutical industry and consists of four core areas.

• Pharmaceutical Quality System: Encompasses the overall quality system, including objectives, quality manual, quality risk management, and knowledge management.
• Management Responsibility: Focuses on the role of management in establishing quality objectives, allocating resources, and ensuring appropriate communication within the company.
• Continual Improvement of Process Performance and Product Quality: Emphasizes the need for ongoing improvement in process performance and product quality through data analysis, corrective and preventive actions, and customer feedback.
• Continual Improvement of the Pharmaceutical Quality System: Highlights the importance of continually improving the quality system itself through the use of management review, revisions to quality policy, and assessment of system performance.

This section will discuss the contents of the guideline model, represented in the ICH Q10 Pharmaceutical Quality System Diagram below.

At the top of the diagram, the Pharmaceutical Quality System (PQS) covers the entire product lifecycle stages, including development, technology transfer, manufacturing, and discontinuation. It complements GMP requirements specific to each country and also applies to investigational products.

The management responsibilities should be present across all stages of the product lifecycle, just like the PQS elements that form one of the pillars of the model.

The lower horizontal bars represent the enablers – knowledge management and quality risk management. These enablers support the PQS goals of product realization, state of control, and continual improvement.

In the following sections, we will further explore the ICH Q10 Pharmaceutical Quality System diagram to understand its key parts and their relations better.

ICH Q10 Lifecycle Stage Goals

The product lifecycle stage goals include the following technical activities for new and existing products according to the ICH Q10 section 3.1.

• Pharmaceutical Development
• Technology Transfer
• Commercial Manufacturing
• Product Discontinuation

Pharmaceutical Development

In the pharmaceutical development phase, the goal is to design products and plan the steps for the manufacturing process.

The company should focus on maintaining consistent process performance and meeting the needs of patients, healthcare professionals, regulatory authorities, and internal customers.

The technical activities conducted in this phase are:

• Developing drug substances
• Developing formulations that include both container and closure systems
• Developing analytic methods
• Developing manufacturing processes and plans for the scale-up
• Manufacture of investigational products

ICH Q10 applies to the development and manufacture of all pharmaceutical products. This also applies to pharmaceutical products still in the development stage and have not yet been approved for marketing, the so-called investigational products.

Technology Transfer

The technology transfer phase aims to transfer knowledge about processes and products from the development to the manufacturing phase.

This phase involves the following technical activities:

• Transfer of products from development to manufacturing
• For marketed products, transfer between manufacturing and testing sites

Commercial Manufacturing

The goal of the commercial manufacturing phase is to help pharmaceutical companies to manufacture products through a process of continual improvement and a state of control.

The pharmaceutical quality system should ensure high and uniform product quality, process performance, suitable controls, identification and evaluation of improvement opportunities, and knowledge growth.

The technical activities that companies must perform are:

• Acquire and control materials
• Provide facilities, equipment, and utilities
• Fabricate packaging materials and labels
• Store, release, or distribute the manufactured products
• Ensure quality control and assurance

Product Discontinuation

Product discontinuation activities aim to manage the final stage of the product lifecycle effectively.

During this phase, the following technical activities should be carried out:

• Management of document retention and sample retention
• Performing continual product evaluation and reporting

Managing the product lifecycle stage goals generates a high volume of documentation that must be handled appropriately to ensure compliance with ICH Q10.

SimplerQMS offers QMS software with robust document management capabilities that simplify the process of document creation, review, approval, retirement, and storage, promoting efficient collaboration among team members.

Our search and retrieval capabilities make it easy to locate and access relevant documents when needed. This ensures quick access to up-to-date information and enables timely responses to inquiries.

Management Responsibilities

Management responsibility states that leadership is essential in establishing and maintaining a company-wide commitment to quality, as per ICH Q10 section 2.

Effective leadership ensures that all company employees understand the significance of quality and are dedicated to upholding it throughout all aspects of the pharmaceutical quality system.

The management should provide guidance, allocate necessary resources, and create a culture that values and prioritizes quality.

Commitment

Management commitment is crucial for ensuring an effective pharmaceutical quality system. Senior management is responsible for establishing the system, defining roles and responsibilities, and ensuring their implementation throughout the company.

In addition, management should actively participate in several tasks, such as:

• System design and maintenance
• Provide support for PQS implementation
• Establish effective communication channels
• Define roles and responsibilities
• Conduct management reviews
• Promote continual improvement
• Allocate necessary resources
• And more

Quality Policy and Planning

Senior management should create a quality policy that outlines the company’s intentions and approach to quality.

The policy is an essential part of the QMS documentation and should encompass compliance with regulatory requirements, emphasizing the continual improvement of the pharmaceutical quality system.

Management should also define and communicate the quality objectives for implementing the quality policy.

Additionally, regular reviews and monitoring of key performance indicators (KPIs) of quality should be conducted.

Resource Management

Management should allocate adequate and appropriate resources to specific products, processes, or sites to ensure the effective implementation and maintenance of the pharmaceutical quality system.

Examples of resources include, but are not limited to, the following:

• Human resources
• Finances
• Materials
• Facilities
• Equipment

Internal Communication

Management should establish and implement effective communication processes within the company to ensure the flow of relevant information between all levels and departments.

These processes should also facilitate the appropriate and timely escalation of product quality and other issues when necessary.

Change in Product Ownership

During product ownership transitions, such as acquisitions, management should acknowledge the complexity of the situation and prioritize the seamless transfer of relevant information and processes.

In addition, it is important to identify and clarify the responsibilities of all companies involved in the process.

Pharmaceutical Quality Management System Elements

The four elements of a pharmaceutical quality management system, as outlined in ICH Q10 section 3.2, are the following:

• Process performance and product quality monitoring system
• Corrective action and preventive action (CAPA) system
• Change management system
• Management review of process performance and product quality.

These four elements work together to establish a comprehensive pharmaceutical quality system that helps ensure the production of safe and effective products while promoting continual improvement.

The PQS elements may be required in part by regional GMP regulations. Still, the ICH Q10 quality management system model aims to enhance them to promote a lifecycle approach to product quality.

Process Performance and Product Quality Monitoring System

Pharmaceutical companies should plan and implement a monitoring system to ensure control over process performance and product quality.

The monitoring system should ensure consistent product quality and identify opportunities for improvement.

Handling process deviations to ensure performance and product quality effectively is essential.

Using an eQMS such as SimplerQMS with the Deviation Management module, companies can streamline the investigation, documentation, and resolution of issues. 

Our software allows companies to relate deviation documents with products, manufacturing processes, and vendors, facilitating the tracking of related data and helping investigate root causes for the issue.

Corrective Action and Preventive Action (CAPA) System

Companies should have a system for implementing corrective and preventive actions (CAPA) based on various sources, such as complaints, deviations, recalls, audit findings, product monitoring data, and more.

Investigations should be conducted using a structured approach to determine the root cause. The level of investigation should be proportional to the level of risk, following ICH Q9 guidelines.

The CAPA methodology should lead to better understanding and improvements in products and processes.

SimplerQMS solution also includes a CAPA Management module that simplifies and automates the corrective and preventive action process.

The software simplifies the escalation of recorded issues to CAPA processes allowing a seamless and closed-loop workflow.

Pharmaceutical companies can streamline CAPA activities for efficient and effective quality issue management, including data collection, routing, notifications, approvals, and follow-up.

Change Management System

An effective change management system should be in place to evaluate, approve, and implement changes properly.

Expert teams with relevant expertise and knowledge should evaluate proposed changes to ensure their technical justification.

After implementation, an evaluation should be conducted to confirm that the change met its objectives.

SimplerQMS offers robust Change Control Management capabilities enabling companies to create, document, and effectively manage all changes.

By utilizing our software, companies can benefit from automatic reminders and notifications that keep employees informed about change requests and their associated activities.

Management Review of Process Performance and Product Quality

Management reviews should ensure that process performance and product quality are effectively managed throughout the lifecycle.

The review process may vary in frequency and level of detail, depending on the company’s size and complexity. It should include efficient communication and escalation mechanisms to address quality issues and involve senior management for in-depth evaluation.

The management review should include the following:

• Review of results from regulatory inspections, audits, and commitments to regulatory authorities.
• Review of quality assessments of customer satisfaction, process, and product monitoring conclusions, and the effectiveness of changes.
• Review of follow-up actions implemented based on previous management reviews.

Knowledge Management and Quality Risk Management

Knowledge management and quality risk management are essential for effectively implementing the pharmaceutical quality system model, according to ICH Q10 section 1.6.

These practices serve as enablers, allowing companies to achieve the objectives outlined in ICH Q10 by facilitating science-based and risk-informed decisions regarding product quality.

What is Knowledge Management?

Knowledge management is the systematic acquisition, analysis, storage, and dissemination of information throughout a product’s lifecycle, from development to commercialization and even discontinuation.

It includes managing product and process knowledge gained through scientific approaches during development activities. Effective pharmaceutical document management processes are essential to ensure that all knowledge is recorded and readily available to relevant individuals.

Various sources contribute to this knowledge, such as:

• Prior knowledge
• Pharmaceutical development studies
• Technology transfer
• Process validation studies
• Manufacturing experience
• Innovation
• Continual improvement
• Change management activities

What is Quality Risk Management?

Quality risk management involves a proactive approach to identify, scientifically evaluate, and control potential risks to ensure product quality.

With SimplerQMS’s Risk Management module, companies can develop risk mitigation plans by defining control measures, implementing preventive actions, and establishing contingency plans.

The software provides a platform for documenting risk mitigation strategies and integrating them with other quality processes to facilitate traceability.

Continual Improvement of the Pharmaceutical Quality System

Continual improvement in the pharmaceutical quality system involves various activities to manage and enhance its effectiveness, as per ICH Q10 section 4.

These activities include ongoing evaluation, analysis, and implementation of improvements to ensure the system delivers uniform and high-quality pharmaceutical products.

Management Review of the Pharmaceutical Quality System

Management should conduct regular reviews of the pharmaceutical quality system using a formal process. These reviews should include evaluating the achievement of quality system objectives and assessing performance indicators that monitor the effectiveness of processes.

The PQS performance indicators cover areas such as:

• Complaints
• Deviations
• CAPA
• Change management
• Feedback on outsourced activities
• Risk assessments
• Internal audits
• Regulatory inspections
• Customer audits
• And more

The outcomes of management review and monitoring of the quality system may lead to several outcomes, including:

• Improvements to the quality system and processes
• Allocation or reallocation of resources
• Training of personnel
• Revisions to quality policy and objectives
• Documentation and communication of review results and actions

Additionally, any relevant issues identified during the review may be escalated to senior management for appropriate attention and resolution.

Internal and External Factors Impacting the PQS

Management should actively monitor various internal and external factors to ensure the effectiveness and adaptability of the pharmaceutical quality system.

Factors monitored by management can include:

• Emerging Regulations: Management should keep up with the latest regulatory requirements, industry guidance, and any emerging quality issues that could impact the PQS.
• Innovations for Enhancing the PQS: Management must be attentive to developments in technology, processes, and methodologies that can contribute to improving the systems.
• Changes in Business Environment: Management should monitor shifts in market trends, customer expectations, and internal organizational goals.
• Changes in Product Ownership: Management must monitor and assess any transitions in ownership to ensure the seamless integration of quality processes, responsibilities, and information.

Role of Pharmaceutical eQMS Software

Pharmaceutical electronic Quality Management System (eQMS) software plays an important role in supporting the implementation of the ICH Q10 guidelines.

The eQMS software can help pharmaceutical companies to improve the quality of their products and services and to comply with regulatory and customer requirements. It automates and streamlines quality processes, enhances communication and collaboration, and promotes a culture of continual improvement.

Although the ICH Q10 Quality System Model can be implemented using a manual paper-based or hybrid QMS, eQMS software provides further improvements.

Paper-based and hybrid systems, while suitable for small companies with sufficient resources, have inherent challenges and limitations. They are prone to errors and damaged documents and require physical space for storage, leading to inefficiencies and potential data loss.

On the other hand, eQMS software offers significant advantages in terms of efficiency, accuracy, and compliance. It provides a digital platform to create, store, and access documents electronically.

SimplerQMS provides fully validated pharmaceutical QMS software.

SimplerQMS offers all Life Science QMS modules integrated to optimize quality management processes. These include document management, CAPA management, change control, employee training, deviation, complaint, supplier, audit, risk management, and more.

Our system helps companies to achieve regulatory compliance with several Life Science requirements, such as GMP guidelines, ICH Q10, FDA 21 CFR Part 11, 210, and 211, EU GMP Annex 11, ISO 9001:2015, and many others.

To better understand the benefits of implementing an eQMS solution, we suggest downloading our eQMS Business Case template.

This valuable tool provides a structured approach for assessing the value of an eQMS tailored to your company’s needs. It also facilitates effective communication of your findings to management. Using a business case analysis, you can explore potential efficiency increases, cost savings, and compliance improvements.

Frequently Asked Questions

What is Q10 in ICH?

The Q10, in the context of ICH, refers to the quality guideline for the pharmaceutical quality system model. The ICH Q10 outlines requirements for implementing a pharmaceutical quality system to ensure the consistent quality of pharmaceutical products throughout their lifecycle.

What Is the Latest Version of ICH Q10?

The latest version of ICH Q10 is the Step 5 version, published in June 2008. Until this article’s publication date (July 2023), there have been no subsequent revisions to the guideline.

What Is the Scope of ICH Q10?

The scope of ICH Q10 is to guide for implementation of a quality management system in the pharmaceutical industry. It applies to the systems involved in developing and manufacturing pharmaceutical drug substances and drug products throughout their lifecycle.

Applying the elements outlined in ICH Q10 should be tailored to each stage of the product lifecycle, considering each stage’s unique characteristics and objectives. The product lifecycle encompasses pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation for new and existing products.

What Are the Objectives of ICH Q10?

The objectives of ICH Q10 aim to achieve three main goals.

Firstly, it aims to establish, implement, and maintain a system that delivers products meeting the quality requirements of customers and regulatory authorities. This objective emphasizes the importance of product realization.

Secondly, the model emphasizes developing and utilizing effective monitoring and control systems to ensure process performance and product quality. This objective aims to maintain a state of control throughout the processes.

Thirdly, the model promotes continual improvement. It encourages identifying and implementing improvements for consistent product quality, process efficiency, and innovation. Quality risk management is essential in prioritizing improvement areas within the system.

What Are the Benefits of Implementing the ICH Q10 Pharmaceutical Quality System?

The implementation of ICH Q10 can provide significant benefits to pharmaceutical companies. For instance, one of the most important benefits of ICH Q10 is to ensure uniform and high product quality and safety.

An effective Pharmaceutical Quality System (PQS) ensures the production of uniform and high-quality products that comply with regulatory requirements. This helps to prevent recalls, rework, and other quality issues, saving companies money and protecting patients.

Another benefit of ICH Q10 is cost reduction. ICH Q10 implementation helps to identify and reduce unnecessary costs associated with quality issues. With ICH Q10, companies improve efficiency and productivity, leading to further cost savings.

ICH Q10 helps to foster a culture of continual improvement by implementing risk management principles and tools to proactively identify, assess, and control risks across the product lifecycle.

Finally, ICH Q10 helps to improve regulatory harmonization. Compliance with ICH Q10 guidelines aligns companies with international guidelines, facilitating inspections and reducing the risk of non-compliance.

How Can Companies Ensure Compliance With the ICH Q10 Pharmaceutical Quality System?

Companies can ensure compliance with the ICH Q10 Pharmaceutical Quality System by following the requirements outlined in the guidance and implementing an internal audit process to ensure adherence to these requirements.

Here are some examples of key steps to ensure compliance with ICH Q10:

• Familiarize themselves with the ICH Q10 guidelines: Companies should thoroughly understand the requirements and recommendations outlined in the ICH Q10 guidelines.
• Conduct a gap analysis: Thoroughly evaluate the company’s existing quality management system against the requirements of ICH Q10. This gap analysis will help identify areas where the company’s current practices align with or deviate from the guideline.
• Implementing a risk-based approach to quality: Identify and assess risks to quality at all product lifecycle stages. Take steps to mitigate those risks.
• Ensure adequate training and awareness: Provide appropriate training to employees to ensure they understand the requirements applicable to their roles and responsibilities.
• Having a well-documented PQS: Have clear documentation describing the PQS and its implementation.
• Conduct regular audits and reviews of the PQS: Periodic inspections should be conducted to ensure that the PQS is effective and implemented correctly.
• Continually improve the quality system: Foster a culture of continual improvement by implementing corrective and preventive actions, analyzing quality data, conducting risk assessments, and actively seeking opportunities for improving the PQS.

What is the Difference Between PQS and QMS?

PQS (Pharmaceutical Quality System) and QMS (Quality Management System) are both quality management systems. The main difference between them is that PQS is specifically designed for the pharmaceutical industry, while QMS is a broader system applicable to any industry.

PQS refers to the quality system implemented by a pharmaceutical company to ensure the quality of its products throughout its lifecycle. It encompasses various elements, including process performance, product quality monitoring system, CAPA system, change management system, and management review, all aimed at achieving and maintaining product quality.

QMS is an overall quality system that defines the policies, processes, procedures, and responsibilities required to ensure that a company’s products or services consistently meet customer and regulatory requirements.

Final Thoughts

The ICH Q10 guideline, also known as the ICH Q10 Pharmaceutical Quality System (PQS), provides a comprehensive framework for pharmaceutical companies to effectively manage quality throughout the product lifecycle.

To implement an effective PQS model, pharmaceutical companies are increasingly adopting eQMS solutions. These solutions streamline quality processes and simplify compliance with regulatory requirements.

SimplerQMS offers an eQMS tailored specifically for pharmaceutical companies. The software automates and streamlines quality processes and supports compliance with ICH Q10 and other regulations, which include GMP, ISO 9001:2015, FDA 21 CFR Part 11, 210, 211, and more.

Want to learn more about how SimplerQMS can support your company QMS? Then book a personalized demo with our experts today and see how our eQMS solution can help you streamline and automate your quality management processes.

The post ICH Q10 Pharmaceutical Quality System (and Role of an eQMS) appeared first on SimplerQMS.

It is a guidance document for interpreting the principles of good manufacturing practice (GMP) for medicinal products.

In this article, we will cover the basics of EU Annex 11, who needs to comply with it, its parts, the requirements, and the differences between 21 CFR Part 11 and Annex 11. We will also discuss how the SimplerQMS eQMS software solution helps ensure compliance with EU Annex 11.

EU Annex 11 was introduced in 2011 as an addition to EudraLex Volume 4 GMP guidelines due to the increased use and complexity of computerized systems employed in GMP-regulated processes.

To help improve compliance with stringent GMP requirements and streamline their quality processes, Life Science companies are progressively adopting electronic Quality Management Systems (eQMS).

SimplerQMS offers EU GMP Annex 11-compliant eQMS software tailored to the needs of Life Science companies. You can schedule a demo to explore how SimplerQMS can benefit your company’s compliance and quality management efforts.

We will discuss the following topics in this article:

• What Is EU Annex 11?
• Who Should Comply With EU Annex 11?
• What Are the Different Parts of EU Annex 11?
• Requirements of EU Annex 11
• What Is the Difference Between 21 CFR Part 11 and Annex 11?
• How Does SimplerQMS Comply With EU Annex 11 Requirements?

What Is EU Annex 11?

EU Annex 11 is a European Union (EU) guideline that outlines the requirements for computerized systems used to manufacture human and veterinary medicinal products.

It is part of the EudraLex Volume 4 GMP guidelines, which set out the requirements that manufacturers of medicinal products can follow to ensure the quality of their products.

The purpose of EU Annex 11 is to establish clear guidelines for using computerized systems in GMP-regulated activities, ensuring the reliability and security of electronic systems.

A computerized system is a combination of hardware and software components working together to accomplish a specific task, according to EU Annex 11.

It applies to all computerized systems used in GMP-regulated activities, including but not limited to:

• Computerized systems used in production, testing, and quality control.
• Computerized systems used to manage documentation and data.

EU Annex 11 requires all computerized systems to be validated and IT infrastructure to be qualified. This means verifying that a computerized system fulfills its intended purpose and operates as expected while ensuring that the IT infrastructure is capable of supporting the system’s intended functions.

The current version of EU Annex 11 was published in 2011. A revision of EU Annex 11 is currently underway and is expected to include updates to reflect the latest technological developments and address new challenges in the area of computerized systems.

Updating the guideline to match current technologies benefits the companies that need to comply with EU Annex 11 since it ensures they use the most up-to-date and secure systems.

Who Should Comply With EU Annex 11?

Companies utilizing computerized systems as part of GMP-regulated activities that operate within the European Union should comply with EU Annex 11.

EU Annex 11 applies to a wide range of companies involved in the pharmaceutical and Life Science industries. Below are some company types that must be compliant since they utilize computerized systems for GMP-regulated activities:

• Pharmaceutical companies: Any company manufacturing medicinal products.
• Contract manufacturing organizations (CMOs): CMOs that manufacture medicinal products on behalf of pharmaceutical companies.
• Clinical research organizations (CROs): CROs must comply with EU Annex 11 if they use computerized systems to manage clinical trials.
• Vendors of computerized systems: Vendors of computerized systems used in manufacturing medicinal products must ensure that their systems meet the requirements of EU Annex 11.

EU Annex 11, while being an important document for the pharmaceutical and Life Science industries, is not a legal requirement. It is a guideline rather than a legally binding regulation.

However, regulatory authorities can consider compliance with EU Annex 11 as a sign of data integrity and quality control. So, compliance with EU Annex 11 is regarded as a best practice within the industries that helps ensure product and process quality, safety, and integrity.

Quality management software can be a valuable tool for helping companies comply with EU Annex 11. By automating and streamlining processes, QMS software helps reduce the risk of errors, maintain data integrity, and ensure regulatory compliance while working more efficiently.

SimplerQMS offers an eQMS solution designed specifically for the Life Sciences industry. Our software is tailored to meet the requirements outlined in different parts of EU Annex 11 and support many other Life Science requirements.

What Are the Different Parts of EU Annex 11?

The different parts of EU Annex 11 provide a structured approach and specific guidance for different stages of computerized system implementation and operation.

EU Annex 11 is divided into three main parts, which are further defined below:

• General Requirements: Provide general guidance on using computerized systems in GMP-regulated activities. It covers risk management, personnel, suppliers, and service providers.
• Project Phase: Focuses on the activities and considerations during implementing and validating computerized systems. It covers topics such as system validation, user requirements specifications, and performance assessment, among others.
• Operational Phase: Addresses the ongoing use and maintenance of computerized systems in GMP-regulated processes. It includes requirements related to data storage, printouts, audit trails, change management, security, electronic signatures, and more.

Requirements of EU Annex 11

EU Annex 11 outlines several requirements for the use of computerized systems in GMP-regulated processes.

Here we will discuss a more detailed breakdown of the different requirements of EU Annex 11.

General Requirements

Risk Management

Risk management should be applied throughout the computerized system’s lifecycle, considering patient safety, data integrity, and product quality. Decisions regarding validation and data integrity controls should be based on a well-documented risk assessment.

Personnel

Close cooperation should exist among relevant personnel, including Process Owner, System Owner, Qualified Persons, and IT. All personnel should possess appropriate qualifications, access authorization, and clearly defined responsibilities to perform their assigned tasks.

Suppliers and Service Providers

Formal agreements between the manufacturer and third parties must be in place when utilizing suppliers for computerized system activities. These agreements should include well-defined responsibilities.

The requirements also apply to IT departments, which should be considered analogous to third parties. Meaning that companies also need to have a clear agreement outlining IT responsibilities.

Project phase

Validation

EU Annex 11 emphasizes the need for manufacturers to validate their systems throughout their lifecycle, ensuring that they meet their intended use and performance.

Computerized system validation includes the following requirements:

• Documentation and reports should cover lifecycle steps, justifying standards, protocols, criteria, procedures, and records based on risk assessment.
• Validation documentation must include change control records and reports on deviations observed.
• An up-to-date inventory of systems and their GMP functionality should be available, with system descriptions for critical systems.
• User requirements specifications should describe system functions throughout the product lifecycle and be based on risk assessment and GMP impact.
• Regulated users must ensure that computerized system development aligns with quality management. Suppliers should be assessed appropriately.
• Validation for customized systems must include formal assessment and reporting of quality and performance measures.
• Evidence of appropriate test methods should be demonstrated considering system parameters, data limits, and error handling.
• Validation needs to ensure data integrity during transfer to another format or system.

Operational phase

Data

Computerized systems should have built-in checks to ensure the correct and secure entry and processing of electronically exchanged data. These checks reduce risks associated with loss of data integrity.

Accuracy Checks

An additional check must be performed for critical manually entered data to verify accuracy. This can be done by a second operator or through validated electronic means. Risk management should consider the criticality and potential consequences of inaccurate data.

Data Storage

Data need to be protected against damage through physical and electronic means. Stored data should be regularly checked for accessibility, readability, and accuracy. Access to data should be maintained throughout the retention period.

Printouts

The system should allow for clear printed copies of electronically stored data. Printouts should indicate if any data has been changed since the original entry for records supporting the batch release.

Audit Trails

Based on a risk assessment, systems should generate an audit trail to record all GMP-relevant changes and deletions. The reason for changing or deleting GMP-relevant data should be documented. Audit trails should be available, easily comprehensible, and regularly reviewed.

Change and Configuration Management

Any changes to a computerized system, including system configurations, must follow a defined procedure and be made in a controlled manner. This ensures that changes are appropriately managed and documented.

Periodic evaluation

Computerized systems should undergo periodic evaluations to remain valid and compliant with EU GMP requirements. These evaluations should cover functionality, deviation records, incidents, problems, upgrades, performance, reliability, security, and validation status.

Security

Controls, whether physical or logical, must restrict access only to authorized personnel. Methods like keys, tokens, identification codes, passwords, and biometrics can prevent unauthorized entry.

The level of security depends on system criticality. Access authorizations should be recorded, and management systems should track users’ actions.

Incident Management

All incidents, including system failures and data errors, need to be reported and assessed. Critical incidents should be investigated to identify root causes and implement corrective and preventive actions (CAPA), if necessary.

Electronic Signature

Electronic signatures should be equivalent to handwritten ones when used to sign electronic records.

Signatures need to be permanently linked to their respective records and include the time and date of signing.

Batch release

A computerized system must limit access for certifying and releasing batches to only Qualified Persons. The system should identify and record the person responsible for the release or certification using an electronic signature.

Business Continuity

Procedures should be in place to ensure the continuity of critical processes during system breakdown. This may involve alternative or manual operation systems.

The time required to switch to alternative arrangements must be based on risk and appropriate for the system and business process. These arrangements should be documented and tested.

Archiving

Data can be archived and needs to be regularly checked for accessibility, readability, and integrity. If any changes are made to the system, such as computer equipment or programs, the ability to retrieve archived data should be ensured and tested.

Archived data must undergo periodic checks to ensure accessibility, readability, and integrity. If any changes are made to the system, such as modifications to computer equipment or programs, the ability to retrieve data must be ensured and tested.

What Is the Difference Between 21 CFR Part 11 and Annex 11?

The difference between 21 CFR Part 11 and EU Annex 11 lies in their regulatory statuses and use in different jurisdictions.

Here are some key differences between EU Annex 11 and FDA 21 CFR Part 11.

• EU Annex 11:
  • It applies to companies operating in the European Union market.
  • Guideline enforced by European Medicines Agency (EMA).
  • Outlines requirements for computerized data systems.
  • Applies to companies performing GMP-regulated activities for the manufacture of medicinal products.
• 21 CFR Part 11:
  • It applies to companies operating in the United States market.
  • Regulation enforced by Food and Drug Administration (FDA).
  • Specifies requirements for electronic records and signatures.
  • Applies to all FDA-regulated industries using electronic records and signatures.

For a more detailed comparison between FDA 21 CFR Part 11 and EU GMP Annex 11, you can refer to our dedicated article.

However, 21 CFR Part 11 and EU Annex 11 share several similarities. For instance, both frameworks require system validation, generation of audit trails, appropriate personnel training, secure data storage, records retrieval, and security measures.

They also emphasize using electronic signatures equivalent to handwritten signatures, linked to records, and accompanied by a time and date stamp.

How Does SimplerQMS Comply With EU Annex 11 Requirements?

SimplerQMS is an eQMS software solution that helps Life Science companies comply with several regulations, including EU Annex 11.

We offer several features that help organizations meet the requirements of EU Annex 11, some of which are described below.

System Validation

SimplerQMS is fully validated according to the risk-based approach of ISPE GAMP5 for computerized systems.

The software remains in a validated state, undergoing revalidation when new versions or standard updates are introduced. This eliminates the need for our clients to invest any additional time and resources in validation activities.

Audit Trails

The system automatically generates time-stamped audit trails, capturing all user actions, including the responsible person, date, and time.

These audit trails preserve previously recorded information and cannot be modified by users, ensuring data integrity.

Personnel Training

SimplerQMS offers our clients personalized system training to ensure users have the necessary knowledge to utilize the QMS software effectively.

Additionally, the system includes training management capabilities, allowing the management of employee training.

Suppliers Management

We provide supplier management capabilities, enabling companies to create and manage supplier-related activities such as qualification, maintaining an approved supplier list (ASL), managing supplier certificates, and much more.

Change Management

SimplerQMS provides a comprehensive change control management solution. It enables the creation, documentation, and management of all changes within the company.

Assignments can be created and delegated, electronically signed upon approval, and notifications and reminders can be set up to ensure the timely completion of change-related processes.

Electronic Signatures

Our eQMS offers EU Annex 11 and 21 CFR part 11 compliant electronic signatures.

Users must authenticate their identity with a unique username and password before signing a document, preventing unauthorized use of signatures.

After signing, the signer’s printed name, date, time, and meaning of the signature are displayed at the bottom of the document. SimplerQMS system automatically links signatures to the respective electronic record, safeguarding against falsification.

Controlled Prints

We offer a controlled printing capability that allows companies to track printouts effectively.

By selecting the print type, the system differentiates between controlled and uncontrolled printouts, adding a unique footer to each printout page.

Security Measures

SimplerQMS integrates with Microsoft Entra ID (previously known as Microsoft Azure Active Directory), offering a cloud-based solution for managing identity and user access.

The system provides features like single sign-on, multifactor authentication, and conditional access. It allows easy management of unique identification codes and passwords and enables periodic updates to prevent password aging.

In addition to the features mentioned above, SimplerQMS provides all QMS modules to streamline quality management processes. These modules include document management, risk management, nonconformance, CAPA, customer complaints, audit management, and more.

The software is designed to address Life Science requirements, helping companies to achieve compliance with EU Annex 11, 21 CFR Part 11, 210, 211, and 820, ISO 13485:2016, ISO 9001:2015, MDR and IVDR, EU volume 4 GMP, ICH Q10, and more.

Explore the advantages of implementing an eQMS in your company by downloading our eQMS Business Case template.

This valuable resource will help you assess the benefits of an eQMS and provide the essential material for effectively presenting your findings to management.

Final Thoughts

EU Annex 11 outlines guidelines for computerized systems used in GMP-regulated activities in the European Union, ensuring they meet specific requirements for their intended use.

By complying with EU Annex 11 requirements, companies improve the reliability and security of their computerized systems, safeguarding product quality and process control.

Many Life Science companies are adopting electronic Quality Management Systems (eQMS) designed to streamline quality processes and support achieving compliance.

SimplerQMS provides a Life Science eQMS solution that helps streamline quality management processes, allows for more efficient work, and helps comply with EU Annex 11 and other Life Science-related requirements.

Learn more about how SimplerQMS can support your company QMS. Book a personalized demo with our quality experts today and see how SimplerQMS can help your company.

The post Annex 11: Computerized Systems (What You Need to Know) appeared first on SimplerQMS.

The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro diagnostic medical devices available in the EU market.

A comprehensive quality management system (QMS) supports manufacturers of in vitro diagnostic medical devices to comply with the IVDR requirements regarding quality.

This article will discuss IVDR, its purpose, the rules for the device classification, some of the QMS requirements, and the role of electronic QMS (eQMS) in supporting compliance with IVDR. We will also give examples that illustrate the important role played by eQMS.

SimplerQMS has helped dozens of Life Science companies transition to a modern electronic QMS system and realize its associated benefits, including easier regulatory compliance. If you want to learn more about how an eQMS can help you streamline quality management processes, book a personalized demo.

Learn more about EU IVDR in the following topics:

• What is EU IVDR?
• What Is The Purpose of EU IVDR?
• IVDR Device Classification
• EU IVDR QMS Requirements
• Frequently Asked Questions About EU IVDR
• The Role of QMS Software in Supporting Compliance With EU IVDR

What is EU IVDR?

The EU IVDR stands for European Union In Vitro Diagnostic Regulations and is the most common way of referring to Regulation (EU) 2017/746.

The IVDR specifies the requirements for placing in vitro diagnostic medical devices and their accessories on the EU market.

It defines an in vitro medical device as any device used in vitro to examine samples derived from the human body to provide relevant information for diagnostic purposes. These can be a reagent, product, calibrator, control material, software, or system used alone or in combination.

This regulation was introduced in May 2017 and has a transition period for manufacturers to comply with the requirements until May 2025 to May 2028, depending on device classification.

Manufacturers of medical devices that wish to place in vitro diagnostic medical devices on the EU market must comply with EU IVDR requirements.

EU IVDR vs. IVDD

EU IVDR replaced Directive 98/79/EC, also known as the In Vitro Diagnostic Directive (IVDD).

Since the IVDD was first issued in 1998, some of its requirements are not aligned with current knowledge of in vitro medical devices.

The IVDD and IVDR share the same basic regulatory process. But IVDR specifies comprehensive requirements for in vitro diagnostic medical devices.

The IVDR adds requirements, such as greater attention to risk management, device classification, reporting to authorities, device traceability, post-market surveillance system, and so on.

Lastly, the IVDD is a directive, and manufacturers could choose to comply with its requirements. However, IVDR is a regulation, so compliance with requirements is mandatory.

EU IVDR vs. EU MDR

Together with IVDR, the European Parliament introduced the Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR).

The MDR specifies requirements to place medical devices in the EU market. It refers to a broad category of medical devices. However, it does not apply to in vitro diagnostic devices, being the requirements for these specified in the IVDR.

So, medical device manufacturers in the EU must comply with the requirements specified in MDR or IVDR, depending on their device type.

The IVDR relates to MDR in many aspects, for instance, concerning the identification and traceability of devices, conformity assessment by Notified Bodies, QMS requirements, and risk management.

The difference between IVDR and MDR can be observed in the clinical evidence needed to demonstrate conformity. For IVDR, clinical evidence, performance evaluation, and performance studies are required. While in MDR, manufacturers must conduct and document clinical evaluation and clinical investigation.

If you want to know more about MDR and how an eQMS can help you achieve compliance with it, read our article on the EU MDR Quality Management System, and the role of an eQMS.

What Is The Purpose of EU IVDR?

The purpose of EU IVDR is to help ensure in vitro diagnostic medical devices placed on the EU market are safe and effective.

The IVDR is part of the overall EU regulation for medical devices. It specifies the requirements manufacturers must comply with in order to sell and market an in vitro diagnostic medical device in Europe.

Compliance and certification to this regulation allow companies to commercialize their products across the European Economic Area. The only exception is devices used exclusively for research, where IVDR does not apply.

For instance, a company that manufactures self-testing devices, such as pregnancy tests or HIV detection assays, must comply with the IVDR and be certified before selling in the EU.

IVDR Device Classification

The IVDR classification rules in Annex VIII specify four classes for in vitro diagnostic devices: A, B, C, or D. These classes are based on the intended purpose of the devices and potential risk for end-users.

• Class A: Have low patient and public health risks. They include laboratory instruments, buffer solutions, and specimen receptacles.
• Class B: Have moderate patient risk and low public health risk. They include pregnancy tests and glucose level tests.
• Class C: Have high patient risk and moderate public health risk. They include sexually transmitted infection tests, cancer markers, and human genetic tests.
• Class D: Have both high patient risk and high public health risk. They include blood groupings, such as ABO and the Rhesus system.

Under the IVDR, only class A non-sterile devices can be self-certified by the manufacturer.

Before marketing, in vitro diagnostic devices from the remaining classes must be audited and certified by a Notified Body.

EU IVDR QMS Requirements

The IVDR has several articles to cover all requirements for in vitro diagnostic medical devices. Among them, the regulation specifies that manufacturers who wish to place their devices on the EU market must implement and maintain a Quality Management System (QMS).

The following topics are some examples of where an efficient QMS can help companies achieve compliance with the IVDR QMS requirements:

1. General safety and performance requirements
2. Technical documentation
3. Responsibility of management
4. Resource management
5. Risk management
6. Post-market surveillance
7. Unique Device Identification (UDI)
8. Reporting to authorities
9. CAPA management

1. General Safety and Performance Requirements

Manufacturers must ensure their devices achieve the performance intended during normal conditions of use. For that, devices need to be designed and manufactured to be suitable for the proposed safety and performance.

To comply with this requirement, design, development, and manufacturing documentation must be planned and controlled. As a result, in this stage, a high volume of documents is generated.

SimplerQMS Design Control Software facilitates document creation with a document template package based on Life Science requirements and pre-configured workflows to guide you through the process.

The system offers Life Science companies the capability of storing data in a cloud-based repository,  defining access levels to documents, relating documents to products, escalating issues to CAPA, and more.

2. Technical Documentation

The technical documentation must be presented in a clear, organized, readily searchable, and precise manner.

It includes several documents, such as device description and specification, reference to previous and similar generations of the device, labels used on the device and its packaging, and so on.

Manufacturers can use Document Control Software, such as the one integrated into the SimplerQMS solution, to help streamline the process of reviewing and approving documents. This core QMS module helps keep documents audit-ready while accurately controlling a high volume of data.

To know more about how to handle documents, read our article about medical device document control.

3. Responsibility of Management

Among many responsibilities, top management must communicate the importance of an effective QMS and the regulatory requirements to all employees. Management will establish the quality policy and objectives of the company.

It is the top management’s responsibility to ensure the effective implementation of the QMS to achieve compliance with IVDR quality systems requirements.

Using an electronic QMS solution like SimplerQMS, you benefit from a single cloud-based system that allows easy access to all QMS data.

The system automatically creates a record of all activities inside the software and provides a time-stamped audit trail. You can easily search and retrieve documents, create customizable document status views, and export data for further analysis.

4. Resource Management

Manufacturers must have a QMS to address resource management to provide adequate resources for conformity assessment activities.

Resource management includes infrastructure, workforce, and suppliers.

For instance, an important infrastructure element is an equipment used in manufacturing the devices. This equipment needs to be adequately maintained to prevent any issues that can impact product safety and quality.

SimplerQMS provides equipment management software to simplify equipment calibration and maintenance tasks. You can create periodic calibration or review tasks, monitor equipment status, set up automatic reminders of actions before due dates, relate specific products to specific equipment, and more.

Another important requirement is having a trained workforce with the necessary skills to perform their functions efficiently. For example, the employees must know the related procedure to use specific equipment, ensuring the tasks are done consistently.

Life Science companies must have a training plan to ensure all employees are competent to perform their specific activities. Training management is one of the core QMS processes in SimplerQMS and helps companies streamline the training process with learning rules, training groups, task assignments, and quizzes.

Regarding suppliers, implementing an eQMS can help medical device companies manage and monitor their suppliers more effectively. SimplerQMS Supplier Quality Management Software allows you to create and maintain Approved Supplier List, schedule supplier audits, and set up automatic reminders for tasks before due dates.

Read our article on the medical device supplier management process to learn more.

5. Risk Management

In vitro diagnostic devices need to be safe and effective for end-users. So, mitigating risks as far as possible is required without adversely affecting the benefit-risk ratio.

The QMS must have risk identification, assessment, and mitigation procedures throughout an in vitro diagnostic device lifecycle.

A complete eQMS, like SimplerQMS, support you with risk management documentation management. You can relate risk documents to products, components, suppliers, customers, equipment, etc. Easily export data and create a traceability matrix and improve risk mitigation.

6. Post-Market Surveillance

Post-market surveillance (PMS) for medical devices is a process by which manufacturers assess the safety and efficacy of their in vitro diagnostic devices in the market.

This requires manufacturers actively gather information regarding their product after it has been sold. Information can be in the form of customer complaints, a literature search on similar devices, and an evaluation of competitors’ issues.

Any quality events need to be addressed within a proper time frame.

SimplerQMS is a comprehensive eQMS that can help you streamline your complaint management workflow.

The system offers features such as document creation using a template package based on Life Science requirements, relating complaint documents to customers or products, setting reminders for task due dates, escalating issues to CAPA, etc.

To learn more check out our article on medical device complaint handling processes.

7. Unique Device Identification

The Unique Device Identification (UDI) is an exclusive numeric or alphanumeric code placed on every medical device in the market, including in vitro diagnostic devices.

The UDI is essential for tracing legal devices that are in conformity and certified to IVDR requirements.

The European Database on Medical Devices (EUDAMED) stores the UDI list, where are all crucial information about the device, such as manufacturers’ details, device risk class, market status, certificates, and more.

8. Reporting to Authorities

According to IVDR, the QMS must have proper procedures for handling communications with competent authorities, Notified Bodies, customers, and other stakeholders.

Regarding reporting to authorities, Life Science companies must summarize the results and conclusions of the analyses of the PMS data and report them together with a rationale and description of any corrective and preventive actions taken.

SimplerQMS offers a reporting functionality where you can justify actions taken and summarize reports. This feature can be enabled or disabled depending on your compliance needs to streamline the workflow.

9. CAPA Management

The QMS should have a robust system for managing corrective and preventive actions (CAPAs) regarding quality events, helping to justify the actions taken and verify their effectiveness.

SimplerQMS supports a comprehensive CAPA management software that can track and manage CAPAs to enforce continuous improvement and resolve issues in a timely manner.

The system offers companies best-practice document templates based on Life Science requirements for complaints, non-conformances, and CAPAs. You can streamline processes with our pre-configured workflows while the system automatically records all actions taken in a time-stamped audit trail.

To learn more about the CAPA process, read our article on the CAPA management process in the medical device industry.

Frequently Asked Questions About EU IVDR

What Does EU IVDR Replace?

The European Union’s In Vitro Diagnostic Regulations (EU IVDR) replaces the In Vitro Diagnostic Directive (IVDD).

The IVDR was implemented in May 2017 and has a transition period until May 2025 to May 2018, depending on the in vitro diagnostic device classification.

Is ISO 13485:2016 Required for EU IVDR?

The ISO 13485:2016 standard is not required for IVDR. However, many manufacturers of in vitro diagnostic devices usually comply with this standard since following it presumes compliance with QMS requirements presented in the IVDR.

What Is the Main Difference Between EU MDR and EU IVDR?

The main difference between EU MDR and EU IVDR is that MDR requirements apply to all medical device types for human use, except in vitro diagnostic devices.

The IVDR is specific for in vitro diagnostic medical devices placed on the EU market.

What Is the Main Difference Between EU IVDR And IVDD?

The main difference between EU IVDR and IVDD is that IVDD is a directive with voluntary compliance, while IVDR is a regulation and so mandatory for every member state in the EU.

IVDR and IVDD have basic requirements in common, but IVDR is a more comprehensive regulation.

Which Countries Does IVDR Apply To?

The EU IVDR applies to all countries in the European Economic Area.

The Role of QMS Software in Supporting Compliance With EU IVDR

Manual paper-based or hybrid QMS have been used traditionally by companies to comply with Life Science regulations and standards requirements. These manual QMS can be successfully used when the company is small and has the necessary resources for the paperwork.

Nevertheless, when considering current regulatory requirements, such as those presented in IVDR, it is evident that manual paper-based and hybrid QMS are becoming increasingly insufficient. These systems bring their own challenges, for instance, physical storage problems, security issues, lost files, and so on.

So, implementing modern, reliable, and efficient QMS software for medical devices, such as SimplerQMS, facilitates quality management. An eQMS provides many features to help achieve compliance with IVDR requirements, streamline QMS processes, enhance efficiency, and lower costs.

Some of the best QMS software solutions for life sciences provide companies with robust and comprehensive QMS modules for document control, change management, employee training, CAPA and non-conformances management, customer complaints handling, supplier management, internal and external audits management, and much more.

SimplerQMS is a state-of-the-art document management system. The system is fully validated according to GAMP5 with monthly re-validation and FDA 21 CFR Part 11 and EU Annex 11 compliant regarding electronic signatures. Our solution covers all Life Science QMS modules in one single place.

Download our eQMS Business Case template to understand the investment in quality management software. The template will assist you in quantifying the investment in an eQMS and help you present it to your company’s decision-makers.

Final Thoughts

One of the most regulated industries in Life Science is medical devices. Due to the vital role medical devices play in patient care, including in vitro diagnostics, this is justifiable.

For instance, the European Centre for Disease Prevention and Control states that within the first two years of COVID-19, over 100 million cases were reported in Europe alone.

These high quantities indicate the number of diagnostic tests conducted across the EU. So, there is a need for strict control by international regulatory authorities.

To place an in vitro diagnostics medical device in the EU market, companies must comply with the requirements presented in the EU IVDR, including QMS requirements.

Many manufacturers choose to achieve compliance with ISO 13485:2016 standard first, as it is presumed to conform with IVDR requirements regarding QMS.

Traditional paper-based or hybrid QMS may still be used at small-sized organizations with sufficient personnel and resources. However, companies are now transitioning to modern and highly efficient eQMS solutions that will streamline the entire QMS process.

If you are interested in implementing an eQMS solution and simplifying achieving compliance with EU IVDR, book a demo of SimplerQMS and talk to our quality solution experts today.

The post What is EU IVDR? A Detailed Introduction (and Role of eQMS) appeared first on SimplerQMS.

Companies must ensure that all procedures impacting the product’s identity, strength, quality, purity, and safety are validated and documented in order to comply with GMP regulations.

The specific GMP requirements may vary depending on the industry and product class. For instance, sterile pharmaceuticals have other specific requirements besides the basic GMP for medicinal products.

A Quality Management System (QMS) needs to reflect the requirements specified in the applicable GMP regulations so that companies can ensure high and uniform product quality.

In this article, we will discuss what GMP is, its importance and origin, some of the relevant regulations, and the role of an eQMS in GMP compliance.

Over the last decade, life science companies have been increasingly adopting electronic QMS (eQMS) to manage their quality processes more effectively than paper-based and hybrid systems.

In this article, you will learn the following:

• Defining GMP
• Origin of GMP Requirements
• Why Are GMP Regulations So Important?
• Major GMP Regulatory Requirements
• Role of an eQMS in Supporting Compliance With GMP Regulations

Defining GMP

Good Manufacturing Practices (GMP) are incorporated into the manufacturing quality management system to help ensure companies manufacture their products with high and uniform quality according to controlled and documented processes.

Good practice requirements vary depending on the specific regulations of each industry.

The general acronym for Good Practice is GxP, where the letter “x” represents all the various processes where the good practice guidelines should be applied. For example, Good Manufacturing Practices are abbreviated as GMP, Good Laboratory Practices as GLP, Good Distribution Practices as GDP, Good Clinical Practices as GCP, and so on.

Regarding GMP, the practices can be associated with manufacturing food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

From now on, this article will focus on life science GMP requirements, especially for the pharmaceutical industry.

The GMP is important for pharmaceutical companies since manufacturing involves the complete product lifecycle, from raw materials and components to the finished product, including its discontinuation.

The GMP helps ensure that drug products are safe, reliable, and efficient for their intended use, complying with regulatory and customer requirements.

Companies must comply with the GMP or cGMP depending on the intended market. Companies to which GMP is applicable are constantly improving, and so are the related requirements. The most up-to-date requirements established are known as current GMP (cGMP).

Compliance with GMP requirements helps ensure the quality and safety of products. With cGMP, companies comply with the most current or updated requirements applicable to the industry.

To learn more about cGMP, you can read our article explaining what are Current Good Manufacturing Practices (cGMP).

Origin of GMP Requirements

Requirements to ensure the production of medicines that meet quality standards track back to 1906 in the United States with the creation of the Food and Drug Administration (FDA).

But it was in 1978 that the FDA established the requirements that became the cGMP in the 21 CFR Part 210 and 211 regulations as we know today.

In Europe, GMP requirements began in 1970 and are compiled in the EU GMP EudraLex volume 4. It is a comprehensive guide referring to the principles and guidelines for the GMP of medicinal products, which includes Directive 2003/94/EC for the principles of GMP regarding medicinal products for human use and investigational medicinal products for human use.

The EU GMP also includes some guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For instance, guidelines Q7 (GMP guide for active pharmaceutical ingredients), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System).

Internationally, the World Health Organization (WHO) published the first draft of GMP guidance in 1968. In 1969, it was acknowledged as an integral part of the quality assurance of pharmaceutical products. More than 100 countries participating in the WHO Certification Scheme can use WHO GMP.

As GMP regulations were created and updated throughout history, pharmaceutical companies needed to control their processes accordingly.

For example, it became imperative to follow standard procedures, test batch samples, keep equipment calibrated, resolve deviations in a timely manner, train personnel, and so on.

A QMS that reflects a company’s specific needs is essential to achieve compliance with GMP requirements.

For instance, if a pharmaceutical company manufactures sterile drugs, there must be processes to control the number of particles in the air of specific areas at rest and in operation. QMS would include the processes and procedures in compliance with the applicable regulations, such as documenting particle testing, training staff to perform control testing, and keeping filtration equipment maintenance logs.

Why Are GMP Regulations So Important?

GMP regulations are essential to ensure manufacturing processes are controlled and well-documented to provide drug products made in accordance with validated procedures.

Compliance with GMP regulations is also important for the following reasons:

Handling Manufacturing Processes

Life science companies need to have well-documented procedures and control of processes. Having everything well described and organized helps ensure the manufacturing process is consistent and produces a uniform, high-quality drug product.

Protecting Products From Adulteration

Drug product batches need to be tested using appropriate samples to check if the established processes can ensure batch uniformity and integrity of drug products. Any deviations from the written procedures must be recorded and justified.

Reducing Costs

Safe and consistent processes help prevent product contamination, deviation, complaints, and recalls. Reducing these quality issues helps pharmaceutical companies avoid rework, changes in processes, and related financial costs.

Improving Customer Satisfaction

GMP provides manufacturing requirements to help ensure drug products meet the expected customer’s quality standards.

Providing safe, reliable, and efficient drug products improves the trust in the company by its customers and helps gain a competitive edge.

Driving Continuous Improvement

Companies must investigate and review complaints, recalls, and returned drug products. These reports can be used for evaluating the quality of each drug product to determine the need for changes in manufacturing processes.

Pharmaceutical companies with products under the GMP requirements must document several manufacturing process elements, such as master production, batch production, and control records.

An efficient eQMS helps manage all quality processes and the high volume of data and documents created throughout the product lifecycle. It also supports companies in achieving compliance with GMP requirements regarding document management.

An eQMS solution, such as SimplerQMS, provides life science companies with a cloud-based system to manage all documentation in one place. You can easily create, link, review, and approve documents while the software automatically records all actions in a document history view for a complete, time-stamped audit trail.

For more information, you can read our article on Quality Management System (QMS) documentation.

Major GMP Regulatory Requirements

Furthermore, we will discuss some of the main regulations and guidelines currently in force by the WHO, the European Union, and the United States regarding GMP. As well as give examples of how eQMS software supports compliance with GMP.

FDA 21 CFR Part 210

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General.

The 21 CFR Part 210 regulation specifies the minimum cGMP for manufacturing, processing, packing, or holding a drug to ensure the product’s safety, quality, and purity characteristics.

Companies must perform activities according to validated written processes and procedures to achieve compliance with this regulation.

This also generates a high volume of documentation to handle.

SimplerQMS solution streamlines document control activities by automating specific tasks in the workflow. We offer preconfigured workflows based on life science requirements to help ensure everything is documented as per the requirements.

The system automates the creation of periodic tasks, email notifications, and reminders to help ensure all activities are completed in a timely manner. You can easily create document relations to maintain full traceability, and much more.

FDA 21 CFR Part 211

Current Good Manufacturing Practice for Finished Pharmaceuticals.

Regulation 21 CFR Part 211 establishes the minimum cGMP for the preparation of drug products for human or animal use.

This regulation includes requirements for personnel, facilities, equipment, labeling, packaging, distribution, deviations, contamination, reports, records, and more.

Among many requirements, pharmaceutical companies need to record and justify any deviation from the written procedures. This involves identifying and documenting deviations, implementing corrective and preventive actions, and recording all activities.

SimplerQMS provides an eQMS with built-in deviation management process handling. Companies can use document templates to create deviation documents, route documents to review, escalate deviations to a CAPA process, set up assignments, analyze data, and more.

FDA 21 CFR Part 212

Current Good Manufacturing Practice for Positron Emission Tomography Drugs.

The 21 CFR Part 212 regulation specifies the minimum cGMP requirements for production, quality assurance, holding, or distributing Positron Emission Tomography (PET) drugs for human use.

One important GMP requirement for radioactive drugs concerns personnel. The quality of PET drugs is in part ensured by trained personnel with the experience to perform their assigned functions, following validated procedures.

Electronic QMS solution also allows companies to manage employee training more easily. Many features of the SimplerQMS training management module help companies achieve well-documented and compliant training processes.

It is possible to create training groups to include several employees in one training assignment. It is also possible to implement learning rules to automatically send notifications about retraining every time a relevant document is updated.

Companies can use quizzes to do training assessments and verify training effectiveness. This allows training effectiveness to be evaluated more accurately than just having trainees read and sign documents.

EU GMP EudraLex Volume 4

This is the fourth volume of “The Rules Governing Medicinal Products in the European Union.”

The EU GMP EudraLex volume 4 contains guidance for interpreting the GMP for medicinal products for human and veterinary use.

It includes other EU regulations to help companies achieve GMP compliance, such as Directive 2003/94/EC.

An important regulatory requirement is the need to conduct inspections. Companies must undergo external and internal audits and propose any necessary corrective measures in case of audit findings.

SimplerQMS simplifies the creation of audit plans for external, internal, and vendor audits through the quality audit management module. Various tasks can be automated, such as periodic task creation, email notifications, reminders, etc., to help decrease the number of manual tasks related to audits.

The system automatically records all activities in documents to create a time-stamped audit trail and provides powerful search functionality to facilitate document retrieval, for instance, during an audit situation.

ICH Q7

GMP Guide for Active Pharmaceutical Ingredients.

The ICH Q7 is a guideline to provide guidance regarding GMP for manufacturing active pharmaceutical ingredients (API).

The ICH Q7 is currently implemented in several countries, such as the United States, Japan, Europe, Brazil, Mexico, Canada, Turkey, and more.

The guide covers many requirements regarding quality management, personnel, facilities, equipment, materials, laboratory controls, complaints, clinical trials, etc.

Among them, pharmaceutical companies must implement a formal change control system to manage all changes in documents and processes that may affect API production.

SimplerQMS offers a robust change control management module that streamlines change request workflow and supports companies’ continuous improvement processes.

Companies can create change requests and easily link them to documents, equipment, and products. The software allows the selection of any number of people to participate in the change request workflow and automated document routing for review or approval.

Actions or periodic tasks can be scheduled to monitor the change’s impact and effectiveness and have the system send automatic reminders and notifications, allowing employees to keep track of change requests and their required activities.

ICH Q9

Quality Risk Management.

The ICH Q9 guideline provides principles and methodologies for quality risk management that can be applied to different aspects of pharmaceutical quality, including manufacturing.

Effective quality risk management helps ensure the quality of the drug product to the end-user by providing ways of identifying potential quality issues during manufacturing.

SimplerQMS helps companies make risk-based decisions by monitoring risk documentation status across all processes. Our risk management software module simplifies the creation of documents for risk assessment and analysis using customizable templates.

Companies can relate risk documents to drug products, equipment, customers, and vendors to ensure the traceability of information.

ICH Q10

Pharmaceutical Quality System

The requirements for one comprehensive model of a pharmaceutical quality system are specified in the ICH Q10 guideline.

The Q10 guideline covers the entire lifecycle of a product and is intended to be used together with regional GMP requirements. Having an effective pharmaceutical quality system in place drives sustainable GMP compliance.

SimplerQMS offers complete pharmaceutical QMS software with all QMS modules available in one solution, including document management, change control, employee training, deviations, CAPA management, and much more.

Our system is customizable and flexible to include all the necessary steps in your processes while supporting your company in achieving compliance.

WHO GMP

The WHO GMP guidelines for biological products are intended to guide national regulatory authorities and manufacturers of biological products.

This guideline covers requirements on the pharmaceutical quality system, risk management, personnel, equipment, quality control, documentation such as batch processing records, and more.

The WHO GMP requirements can be used as national requirements if a country desires, to adopt the guidelines entirely or with justified modifications.

Those are some of the relevant regulations regarding GMP.

Other regulations can apply to life science companies in the pharmaceutical industry, such as 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) or 21 CFR Part 600 (Biological Products).

Always make sure to verify the regulatory requirements applied to the country and intended market you want to operate in!

Role of an eQMS in Supporting Compliance With GMP Regulations

Companies can use traditional paper-based or hybrid QMS to comply with life science requirements. A manual QMS can be used successfully in small companies with adequate resources for handling the paperwork.

However, traditional formats of quality management systems have some challenges, such as the potential of losing documents and records, physical storage issues, unauthorized access to files, etc.

Also, manual processes can be tedious and difficult to track. Companies may find themselves facing difficulties when it comes to maintaining compliance with GMP regulations.

This is where an electronic QMS (eQMS) can help. Best eQMS software solutions offer the ability to automate many tasks associated with processes, such as document management, change control, employee training, and many more.

Implementing an eQMS system ensures that organizations meet all their quality management system requirements while supporting GMP compliance.

SimplerQMS provides an eQMS that is both secure and reliable. Our software provides broad process support, from document and change management, to risk management, employee training, vendor management, and more. It makes it much easier for organizations to maintain compliance with GMP regulations across all quality management processes.

With SimplerQMS, GMP documents and records can be created using customizable templates, and preconfigured workflows help ensure the process follows the necessary steps, and all necessary data is collected.

Furthermore, the system is fully validated according to ISPE GAMP5 and is re-validated upon the creation of a new version or upon applying standard updates. It is also compliant with FDA 21 CFR Part 11, which sets the guidelines for electronic signatures and electronic records, as well as EU GMP Annex 11, which provides good manufacturing guidelines for computerized systems.

All the above and many other features provide a software solution that makes GMP compliance easier, saving time and money in the process.

If you are unsure whether an investment in an eQMS is worth it for your company, then check out our eQMS Business Case template – which you can download below.

It can help you assess the value of an eQMS for your company and includes the necessary material for presenting your findings to the management.

Final Thoughts

Highly regulated life science industries, such as pharmaceutical and biotechnological companies, must comply with several regulations and standards depending on the intended market.

Among them, the GMP regulations help ensure medicinal products are produced and controlled according to quality requirements.

Having a QMS that reflects the applicable GMP requirements allows companies to achieve compliance and place safe, reliable, high, and uniform-quality drug products in the market. The QMS needs to have all the relevant processes and procedures in place to control the processes related to manufacturing drug products according to the GMP requirements.

Traditional paper-based and hybrid QMS can be used for small companies with adequate resources to do the manual work. However, implementing an eQMS can be instrumental in supporting GMP compliance, as it provides automation and streamlining of processes.

Book a personalized demo and talk to our experts if you want to learn more about how SimplerQMS can help streamline your quality management processes and support compliance with GMP regulations.

The post How GMP Compliance Is Reflected in QMS (Role of eQMS) appeared first on SimplerQMS.

The medical laboratory is essential to patient care since decisions on patient treatment are made based on laboratory results. The standard provides a structure that enables these organizations to consistently develop their quality management systems (QMS) and assess their own competence.

In this article, we will discuss what the ISO 15189:2022 standard is all about, its purpose and requirements, and how an electronic QMS can help medical laboratories achieve compliance, including some case examples.

Although laboratories can achieve compliance with Life Science requirements using paper-based and hybrid QMS, having an electronic QMS (eQMS) helps to streamline quality processes.

Learn about the ISO 15189:2022 standard by exploring these topics:

• What Is the ISO 15189:2022 Standard?
• Why Is the ISO 15189:2022 Important?
• Benefits of Being Compliant With the ISO 15189:2022
• Key Requirements for the ISO 15189:2022 Compliance
• The Role of QMS Software in Supporting Compliance with the ISO 15189:2022
• Frequently Asked Questions About the ISO 15189:2022

What Is the ISO 15189:2022 Standard?

The ISO 15189:2022 is an international standard that establishes requirements for quality and competence in medical laboratories. It contains many requisites, including planning and implementing actions to address risks and opportunities for improvement of the system and processes.

The standard can be used for several healthcare services, such as medical laboratories, diagnostic imaging, respiratory therapy, physiological sciences, blood banks, and transfusion.

The goal of the ISO 15189:2022 is to promote patient well-being and satisfaction by improving the trust that their medical laboratories are competent and quality-assured.

For that, the requirements comprehend all aspects of QMS in a medical laboratory, including sample collection and handling, risk management, employee competence requirements, metrological traceability of results, waste disposal, and so on.

This standard is based on the ISO 9001:2015 regarding general requirements for QMS, focusing on medical laboratories, as well as on the ISO 17025:2017 regarding testing and calibration competence requirements for laboratories to ensure equipment accuracy.

Furthermore, the ISO 15189:2022 incorporates and replaces the requirements for point-of-care testing (POCT), previously in the ISO 22870:2016. These requirements are intended for any test performed at or near a patient and at the site where care or treatment is provided, such as blood glucose monitoring and home pregnancy tests.

Note that the ISO 15189:2022 per se is not a mandatory standard but can be used to recognize the competence of medical laboratories by patients, customers, and regulatory authorities.

However, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) survey on the accreditation process in European countries shows that some countries, such as France and Hungary, decided to integrate this standard as a mandatory requirement for all fields of laboratory medicine.

Other countries use it as a requirement for partial areas, like Belgium for molecular biology tests, Ireland for immunohematology and blood transfusion, and Lithuania for biochemistry and hematology.

In the United States, Clinical Laboratory Improvement Amendments (CLIA) requirements, expressed in the FDA 42 CFR Part 493, specify the requirements that all laboratories must meet to be certified to perform human testing.

Although the ISO 15189:2022 and the FDA 42 CFR Part 493 can be comparable in many aspects, this standard is not present in the FDA Recognized Consensus Standards, so it cannot replace a CLIA certification.

If you are a medical laboratory, please always refer to the applicable regulation in your country.

As described further in the article, various requirements related to QMS are outlined in the ISO 15189:2022. Paper-based or hybrid QMS systems can be used to support achieving compliance with regulatory standards, depending on the medical laboratory size and available resources to do all the manual work.

However, an eQMS helps streamline processes and offers more efficient support to achieve compliance with life science requirements.

SimplerQMS offers eQMS software that helps clinical and medical laboratories to achieve and maintain compliance with the ISO 15189:2022. It helps manage and document processes related to quality management, compliance, and competence across different departments in a paperless way.

Why Is the ISO 15189:2022 Important?

The ISO 15189:2022 standard is important because it sets medical laboratories’ quality and competence requirements. These two components are crucial to consistently achieving accurate and reliable results.

Patients’ treatment depends on laboratory results, and inaccuracies can lead to significant health problems. The ISO 15189:2022 facilitates harmonizing methods and procedures to provide patients with the same high level of care in any medical organization worldwide.

The standard helps improve medical laboratory credibility since complying with the requirements indicates that organizations have efficient and accurate processes in place.

In addition, the ISO 15189:2022 is essential for laboratory workers’ safety. Hazardous materials are often present in laboratories, so proper protection is necessary. The standard also outlines requirements regarding facilities and environmental conditions to help ensure that the personnel operating in the medical laboratory is not exposed to microbial contamination, radiation, humidity, temperature, sound, vibration, etc.

Benefits of Being Compliant With the ISO 15189:2022

The ISO 15189:2022 compliance provides many benefits to medical laboratories.

Overall, it is a useful approach to add credibility to your organization by demonstrating that products and services meet the expectations of customers and stakeholders regarding quality and competence.

Other benefits of the ISO 15189:2022 compliance include the following:

Increased Effectiveness of QMS

Complying with the requirements of this standard indicates that medical laboratories have an effective quality management system in place. Quality indicators can be used to evaluate performance during pre-examination, examination, and post-examination processes to drive continuous improvement.

Quality indicators, such as complaints and the number of CAPAs, are used to evaluate the performance of processes to drive continuous improvement, for instance.

For example, medical laboratories can investigate how many patient samples have been improperly collected, compare them to the total number of samples received, and then determine a threshold. When the threshold is reached, retraining of the staff takes place.

Risk Reduction

The ISO 15189:2022 provides a framework that, between many benefits, allows medical laboratories to identify and manage risk. Planning actions concerning potential risks helps to reduce harm to patients, laboratory personnel, the public, and the environment.

Higher Customer Satisfaction

With well-rounded and documented processes, activities are more likely to be carried out with competence and on time to meet all patients’ needs.

This way, patients trust medical laboratories to manage their data with impartiality and confidentiality while providing accurate results.

International Recognition

The ISO 15189:2022 compliance indicates that medical laboratories provide the same secure, competent, and high-quality services worldwide.

This standard is integrated into some countries as a mandatory requirement, making test results from the ISO 15189:2022 compliant and certified medical laboratories accepted internationally.

For example, some countries require travelers from tuberculosis (TB) endemic regions to provide a negative TB test to apply for a visa. To be accepted overseas, these tests must be performed by the ISO 15189:2022 compliant and certified laboratory.

Cost-Saving Processes

Compliance with the ISO 15189:2022 requirements demonstrates that the medical laboratory’s processes are efficient, providing accurate test results. By ensuring results are valid, laboratories could also save costs related to re-testing.

Overall, process improvement can lead to fewer errors and waste, enabling long-term cost savings.

Key Requirements for the ISO 15189:2022 Compliance

The ISO 15189:2022 is the fourth edition of the standard and has some improvements from the 2012 version.

In this standard, medical laboratories can find a greater emphasis on risk management, requirements for point-of-care testing (POCT), and an alignment with the ISO 17025:2017 that resulted in the incorporation of management requirements.

Sections 1 to 3 are related to the scope, normative references, and terms and definitions, respectively. This article will not focus on these sections.

If you want to learn more, please refer to the complete ISO 15189:2022 standard.

Confidentiality (Section 4.2)

Medical laboratories must manage all patient information given during examination with privacy and confidentiality. Relevant information about the patient’s well-being can be made available to other health professionals at the patient’s request.

For that, laboratories need to implement processes to ensure patient data can only be accessed by specific personnel.

Using a system with robust document controls, like SimplerQMS, medical laboratories can easily protect patient data and ensure its confidentiality. SimplerQMS software can set up document access levels by relating specific people to relevant documents, ensuring no unauthorized access to patient data.

The system allows laboratories to store all information in one place, a cloud-based system, eliminating the need for physical storage and the possibility of lost documents.

Recommended Reading: Laboratory Document Control: A Simple (But Complete) Guide

Quality Management (Section 5.4.2)

All medical laboratories that comply with the ISO 15189:2022 must have a QMS in place. It also helps improve laboratories’ overall performance and provides a sound basis for sustainable development initiatives.

For example, organizations must establish, document, implement and maintain laboratory QMS documentation regarding processes, systems, and records. Documents include policies, procedures, work instructions, and records to support the execution of activities.

It is possible to utilize a paper-based or hybrid QMS, depending on the size and resources available to the laboratory. However, an eQMS can streamline processes and activities involved in the quality and accuracy of test results.

SimplerQMS provides a complete QMS software solution designed specifically for life science industries. The system comes with pre-configured workflows, a complementary template package, and all core QMS modules, making the transition to an electronic QMS simpler and faster.

Recommended Reading: Laboratory Quality Management System (QMS)

Risk Management (Section 5.6)

Laboratory management must plan and implement processes for identifying potential harm to patients and opportunities to improve patient care.

Additionally, to this standard, medical laboratories can refer to the ISO 22367:2020, which provides more details for managing risk in medical laboratories, and the ISO 35001:2019 establishes the biorisk management principles.

Laboratories can also benefit from risk management capabilities built into an eQMS solution,1 like SimplerQMS. It helps medical organizations assess and document potential risks, prioritize them according to severity level, and assign actions to reduce the risk.

Continuing Education and Professional Development (Section 6.2.4)

The ISO 15189:2022 establishes that an education program needs to be available to personnel in management and technical processes.

Medical laboratories must have processes to determine the competence of personnel performing work affecting service quality.

Employee training management solution, an integral part of a complete eQMS solution, supports laboratories in achieving efficient, well-documented, and compliant training processes.

The system supports the assigning of training activities, sends email notifications and reminders for scheduled training, allows you to evaluate the effectiveness of training provided via quizzes, and tracks the progress of each trainee.

Equipment Management (Section 6.4)

Laboratory equipment must be appropriately handled, used, and maintained to ensure functionality and prevent contamination of personnel and results.

SimplerQMS also offers equipment management capabilities to help medical laboratories streamline equipment management processes, including calibration activities.

Externally Provided Products and Services (Section 6.8)

The ISO 15189:2022 specifies requirements for supplier services that affect laboratory activities. For instance, medical laboratories must have processes to shortlist, qualify, select, onboard, and periodically evaluate suppliers’ performance.

Imagine that a medical laboratory needs to hire a pipette calibration service from another organization to ensure the volume of reagent used in the sample processing is consistently accurate. In such a case, it would be necessary to shortlist possible calibration companies, select one that complies with the regulatory requirements, and onboard it into the laboratory management system.

SimplerQMS helps organizations manage all supplier management-related processes and documents, such as contract, survey, evaluation, and certificate management, in single cloud-based storage for easy access by authorized users.

Approved supplier lists (ASL) can be easily created and managed in the system to overview the current status of suppliers regarding certifications and more. This also provides evidence that external products and services meet the laboratory’s established criteria.

Complaints (Section 7.7)

Medical laboratories must have a process for handling complaints. It includes tracking and recording the complaint and the actions to solve it.

For instance, the resolution of complaints needs to be reviewed and approved by staff not involved in the complaint issue to guarantee impartiality.

Using an eQMS facilitates complaint management processes. With a solution such as SimplerQMS, medical laboratories can manage all complaints in one cloud-based system capable of linking all relevant documents and defining access levels to protect documents from unauthorized views.

You can initiate a complaint from a customer file and escalate it to a CAPA, if necessary while having all these documents and processes easily related with just a few clicks.

Control of Management System Documents (Section 8.3)

Medical laboratories must control all internal and external documents.

These documents need to be uniquely identified to ensure traceability, periodically reviewed, and protected from unauthorized access. Also, all changes need to be tracked, and up-to-date versions of applicable documents need to be available for the personnel.

Clinical and medical activities generate a high volume of data and documents. It is necessary to implement document control tools to manage these documents efficiently.

For instance, pH meters must be cleaned and calibrated according to an SOP. The laboratory staff can miss the current version of the SOP, especially if it is only available in paper form. With an eQMS, medical laboratories can track and view the status of all documents in the system.

By implementing an eQMS with effective document control software like SimplerQMS, laboratories can streamline document creation using document templates. Only the current version of the document can be accessed, preventing obsolete documents from being used.

Medical organizations also need to control modifications made to existing documents, handle change request approval, and manage change implementation. With the SimplerQMS change control management module, medical laboratories can easily manage changes to their documents, processes, products, and templates.

Nonconformities and Corrective Actions (Section 8.7)

The ISO 15189:2022 outlines the actions in case of quality events.

Medical laboratories need to identify the cause of the issue and implement steps to ensure it does not occur again. These measures can be escalated to preventive and corrective actions (CAPA) if the laboratory seems fit.

For instance, if the equipment was calibrated but the calibration label was not updated. A CAPA can implement a checklist for the calibration procedure with an “update calibration status” item as a final step.

Using QMS software simplifies these processes. SimplerQMS non-conformance and CAPA modules help to ensure that all nonconformities (e.g., customer complaints, audit findings) are recorded, and the necessary actions are tracked. The system allows you to assign tasks and set timelines for completion.

Recommended Reading

• What Is Non-Conformance And How to Minimize It
• What is Non-Conformance Report in Life Sciences?

The Role of QMS Software in Supporting Compliance with the ISO 15189:2022

Medical laboratories must have processes to ensure the validity and accuracy of test results. For that, they can comply with the requirements for quality and competence specified in the ISO 15189:2022 standard.

Using paper-based or hybrid QMS can be viable for small medical laboratories with adequate resources to handle the manual paperwork. However, all sizes of medical organizations can benefit from an eQMS solution.

SimplerQMS provides an integrated eQMS for medical laboratories to help achieve compliance with the ISO 15189:2022 requirements.

The QMS software facilitates the documentation of all processes and stores all data in one secure cloud-based system. Medical laboratories can determine access levels to protect patients’ confidential records and share them with other healthcare providers from anywhere.

SimplerQMS solution offers core QMS modules to streamline tasks, such as SOP creation, notifications, employee training, document changes, CAPA, audits, document collection, and so on.

Having an eQMS in place not only supports the ISO 15189:2022 compliance but also presents economic benefits.

If you are interested in learning more about whether eQMS software is the right solution for your organization, you can download our free eQMS Software Business Case template.

You will receive a spreadsheet with all the necessary information and calculations to help you understand the financial impact of investing in quality management software.

Frequently Asked Questions About the ISO 15189:2022

Is the ISO 15189:2022 Mandatory?

Compliance with the ISO 15189:2022 is voluntary, however, certain countries may require certification to this standard as it is internationally recognized and agreed upon by experts. It is used to recognize the quality and competence of medical laboratories by patients and regulatory authorities in some countries, such as France, Hungary, Belgium, Germany, and more.

If you are a medical laboratory, always check your national regulation to confirm if this standard applies to you!

Who Uses the ISO 15189:2022 Standard?

The ISO 15189:2022 is used by medical laboratories in developing their management systems and assessing their competence.

This standard is also utilized to confirm or recognize the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies.

An institution is considered a medical laboratory if it is responsible for testing human samples. These include microbiological, immunological, biochemical, cytological, and other tests.

What Is the Difference Between the ISO 17025:2017 and the ISO 15189:2022?

The main difference between the ISO 17025:2017 and the ISO 15189:2022 is the focus on patient and medical care.

The ISO 17025:2017 establishes requirements for the competence of general testing and calibration laboratories.

The ISO 15189:2022 specifies the requirements for quality and competence in medical laboratories. It applies to laboratories where human samples are tested.

For instance, a complete human blood count test is performed at the ISO 15189:2022 certified medical laboratory. In comparison, a rabies test for dogs can the carried out at the ISO 17025:2017 certified laboratory.

Is the ISO 15189:2022 the Same as CLIA?

Although the ISO 15189:2022 and US Clinical Laboratory Improvement Amendments (CLIA) can be comparable regarding laboratory conditions to perform human testing, they are not the same.

The specific regulations for medical laboratories to comply with CLIA are found in the FDA 42 CFR Part 493.

Certification to the ISO 15189:2022 does not meet the FDA 42 CFR Part 493 requirements and cannot replace a CLIA certification in the US market.

Final Thoughts

Medical laboratories aim to promote patients’ welfare and satisfaction by providing competent laboratory services and accurate test results.

The ISO 15189:2022 is an international standard that specifies medical laboratories’ quality and competence requirements. Laboratories that comply with this standard demonstrate the ability to provide services that consistently meet customer and applicable regulations.

Maintaining medical laboratory documentation always updated and compliant can be a complex process involving a high volume of information. Having a robust QMS is essential to manage quality management processes.

Paper-based and hybrid QMS can be used by small laboratories with enough resources. However, it can present challenges, such as human errors, lost documents, time-consuming audits, the need for physical storage, etc.

A straightforward solution is an eQMS solution made specifically for life sciences. QMS software by SimplerQMS supports medical laboratories and other companies in the life science industry, in streamlining quality management processes.

SimplerQMS offers a complete solution with core life science QMS modules, such as document control, audit management, supplier management, equipment management, non-conformance management, CAPA management, and much more.

If you are interested in learning more about our eQMS solution and how it can help you make compliance with the ISO 15189:2022 easier, book your free demo with one of our quality solution experts today.

The post What is ISO 15189? A Detailed Introduction (and Role of eQMS) appeared first on SimplerQMS.

A QMS that meets the ISO 13485:2016 requirements demonstrates a commitment to quality and customer satisfaction, which is essential to any medical device manufacturer.

This article will discuss the purpose of the ISO 13485:2016 standard, its main requirements, and eQMS software’s role in supporting compliance with the ISO 13485:2016.

Learn about the ISO 13485:2016 standard by exploring these topics:

• What Is the ISO 13485:2016 Quality Management System Standard?
• What Is the Purpose of ISO 13485:2016 QMS Standard?
• What Are the Requirements of ISO 13485:2016 Standard?
• What Does It Mean To Be ISO 13485:2016 Certified?
• How To Be ISO 13485:2016 Certified?
• Benefits of Being ISO 13485:2016 Certified
• Role of an eQMS in Supporting Compliance With the ISO 13485:2016
• Frequently Asked Questions About ISO 13485:2016

What Is the ISO 13485:2016 Quality Management System Standard?

The ISO 13485:2016 is an international regulatory standard that specifies medical device manufacturers’ Quality Management System (QMS) requirements. It can be used by an organization involved in one or more stages of the life cycle of a medical device.

Any company involved in the design, development, manufacturing, storage, delivery, installation, or technical support of medical devices must be able to prove that its products and related services consistently meet customer and regulatory requirements.

Medical device manufacturers that comply with the ISO 13485:2016 requirements have processes in place to ensure device quality and safety to their customers.

The processes required by the ISO 13485:2016 standard concern quality management for medical devices, much like the FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR).

The FDA QSR specifies the current good manufacturing practice requirements for finished devices in the US market for human use.

Both the ISO 13485:2016 and FDA 21 CFR Part 820 requirements are entirely comparable. And in February 2022, the FDA issued a proposed rule to harmonize the 21 CFR Part 820 with the ISO 13485:2016.

The goal is to align the US regulation more closely with the international consensus standard of QMS for medical devices used by many other regulatory authorities worldwide in the years to come.

The ISO 13485:2016 is also related to the EU Medical Device Regulation (MDR) regarding the QMS requirements for medical device manufacturers.

However, the MDR is more comprehensive than the ISO 13485:2016 and specifies other requirements for medical devices.

Manufacturers of medical devices in the European market usually adhere to the ISO 13485:2016 standard. ISO 13485:2016 certified manufacturers can speed up the MDR certification process regarding the QMS requirements.

To become ISO 13485:2016 certified, obtain FDA clearance, and MDR certification, medical device manufacturers must have a QMS that complies with the relevant regulations and standards requirements.

It is possible to comply with the QMS requirements in these regulations and standards using paper-based or hybrid QMS systems, but it can be challenging. Various issues can arise, including losing documents, physical storage issues, auditing problems, etc.

While with electronic quality management systems (eQMS), medical device manufacturers can count on workflow automation, electronic signatures, data security, and cloud-based storage. It is also possible to ensure responsibility by assigning specific people to specific tasks.

That is why companies are increasingly turning to eQMS software solutions. Electronic QMS solutions allow medical device companies to effectively manage their QMS documentation and simplify the process of achieving compliance with the ISO 13485:2016. 

Such software offers a convenient way to manage the required records and documents, including procedures and protocols. It also streamlines various processes, such as managing customer complaints, changes, non-conformances, and CAPAs.

SimplerQMS is an eQMS software solution that offers a cloud-based platform to help medical device companies manage their documentation and processes in compliance with the ISO 13485:2016.

What Is the Purpose of ISO 13485:2016 QMS Standard?

The purpose of ISO 13485:2016 is to set forth the QMS requirements for medical device organizations to ensure their devices and services consistently meet customer and regulatory requirements.

Having ISO 13485:2016 compliance facilitates medical device manufacturers to align their QMS more closely with relevant requirements in FDA 21 CFR Part 820 and MDR.

Previously, in the European Economic Area, the Medical Devices Directive (MDD) set all the necessary steps to ensure that medical devices were placed on the market legally and safely. Being a directive, it was voluntary and individual countries could create their regulations.

The MDD was replaced by the Medical Device Regulation (MDR) in May 2021.

The MDR is a regulation and, therefore, mandatory for the medical devices industry in the EU. It ensures that medical devices produced in or supplied to the EU must be safe for the end user and of high and uniform quality. MDR covers the whole device’s life cycle processes and specifies the QMS requirements for medical devices.

Since the ISO 13485:2016 is a QMS standard for the medical device industry, compliance with it reflects the QMS requirements stated in the MDR and FDA 21 CFR Part 820.

What Are the Requirements of ISO 13485:2016 Standard?

ISO 13485:2016 standard has several sections to cover all the requirements for QMS. It brings a greater emphasis on risk management and risk-based decision-making than in previous editions.

Sections 1 to 3 are related to the scope, normative references, and terms and definitions. This article will not focus on these sections. If you want to learn more, please refer to the complete ISO 13485:2016 standard.

Quality Management System (Section 4)

Medical device organizations must document QMS-related procedures and ensure they comply with the ISO 13485:2016 requirements.

This means manufacturers need to implement and maintain processes regarding quality manuals, medical device files, control of documents, control of records, and any other procedure regarding the manufacturing of medical devices.

Documentation is a core element of QMS. Having well-documented procedures ensures that processes are consistently performed, and that personnel is aware of the processes for each task.

Document changes also need to be controlled. The change control ensures the distribution and record of responsibility, records the workflow of the change and provides audit traceability.

SimplerQMS provides a complete eQMS solution for the medical device industry, having all QMS modules in place, including the core modules such as document control, change management, training, audit management, risk management, CAPA, non-conformance, supplier management, and so on.

Moreover, any computer software used as an eQMS should always be fully validated. After any update, a full validation must be performed, and all validation documentation must be readily available at any time.

The SimplerQMS system is fully validated according to GAMP5. We perform monthly re-validation of the system, freeing our customers from spending time on software validation activities. The system fully complies with the ISO 13485:2016, 21 CFR Part 11 and 820, and the EU Annex 11 requirements regarding validation and electronic signatures.

Management Responsibility (Section 5)

Medical device companies’ top management must ensure that responsibilities and authorities are defined, documented, and communicated within the organization.

The top management is responsible for monitoring the efficiency and effectiveness of the QMS.

Resource Management (Section 6)

Medical device manufacturers must provide the necessary resources to implement QMS, maintain effectiveness, and meet applicable regulatory and customer requirements. These resources can be in the form of infrastructure and personnel ongoing training and competencies management.

Infrastructure includes buildings, workspace, equipment, transport, and communication systems. All maintenance activities are required to be documented.

Regarding the equipment, it is important to have QMS software that supports equipment management. SimplerQMS offers a solution that allows medical device organizations to create a list of all equipment, monitor the current state of equipment, schedule calibrations, send automatic notifications for maintenance tasks due dates, and more.

One important part of personnel resources management is providing training. Employees need to receive training in a wide range of documents to ensure that their competencies match company requirements and that the knowledge of their impact on the quality and safety of the products is known.

You can achieve efficient, well-recorded, and compliant training processes with SimplerQMS Training Management Software.

Various features are available, including creating training plans, routing training plans for review or updating, measuring training effectiveness with customizable quizzes, monitoring training with status reports, and automatically setting periodic tasks so training will be repeated after one year, for example, and much more.

Product Realization (Section 7)

As part of product realization, efficient quality procedures are established for the design, development, manufacture, packaging, labeling, and transportation of every medical device manufactured by your company.

When using an eQMS, such as SimplerQMS, the final product release document can easily be reviewed, approved, and linked to all the people and processes related to medical device manufacturing.

Design and Development (Section 7.3)

The design and development of a medical device must be planned and controlled to ensure performance, usability, and safety requirements according to the intended use.

A high volume of documents is generated during this phase of a medical device lifecycle, and all input, output, and changes need to be recorded.

SimplerQMS Design Control Software facilitates the development of your medical devices by managing design and development plans, design review, verification, validation, and design transfer.

The system allows the creation of customizable views, snapshots of document collections, and more. You can also relate design control documentation to relevant documents and regulatory chapters.

Recommended Reading: Design Controls for Medical Devices

Purchasing (Section 7.4)

This subsection of the ISO 13485:2016 specifies that manufacturers must select and evaluate suppliers.

For instance, manufacturers need to have a plan for monitoring, re-evaluating, and auditing suppliers. During these audits, eventual audit findings must be assessed and documented.

Medical device organizations can manage and monitor suppliers more effectively with eQMS software that also supports supplier management processes.

SimplerQMS Supplier Quality Management Software allows you to create and maintain Approved Supplier List, schedule supplier audits, set up automatic reminders for tasks’ due dates and certificate expiration dates, etc.

Recommended Reading: Medical Device Supplier Management Process (8 Steps)

Control of Monitoring and Measuring Equipment (Section 7.6)

Medical device organizations must monitor and control equipment related to devices providing evidence of device conformity with the ISO 13485:2016 standard.

Among other things, companies need to implement and record periodic equipment tasks, such as calibrations and adjustments, according to the applicable guidelines.

SimplerQMS supports equipment management processes, including calibration and maintenance activities.

For instance, the system sends notifications to specific personnel to inform them about a calibration or maintenance task before due dates. It automatically creates a complete equipment calibration and maintenance log readily available for audits.

Measurement, Analysis, and Improvement (Section 8)

This section of the ISO 13485:2016 emphasizes the monitoring, measuring, analyzing, and improving processes needed to demonstrate product conformity and ensure the effectiveness of the QMS.

To comply with post-market surveillance requirements, medical device manufacturers must gather and monitor information if their device has met customer requirements, using appropriate methods, including statistical techniques, feedback, and customer complaints.

Complaint handling is one of several important processes since it is through complaints that customers give feedback on non-conformance and adverse events of medical devices.

In SimplerQMS software, companies can create complaint documents using templates based on requirements. These complaints can be initiated from several different sources. SimplerQMS has pre-configured workflows that can guide you in handling complaints.

One way of handling a complaint can be escalating it to a CAPA. For example, during an external audit, any audit findings must be escalated to a CAPA.

SimplerQMS CAPA Management Software allows medical device companies to initiate the CAPA process directly from audit findings with just a few clicks and link all documents together.

Furthermore, companies can easily use SimplerQMS Audit Management Software to schedule, conduct, document, and report on internal, regulatory, and supplier audits. This helps manage and track audit-related activities, assign tasks and responsibilities, and ensure the timely completion of assignments.

What Does It Mean To Be ISO 13485:2016 Certified?

To be ISO 13485:2016 certified means that an organization has a QMS that complies with the requirements of the ISO 13485:2016 standard and is certified by an external certification body.

Medical device companies can choose the scope of their certification. This means a manufacturer can have a QMS ISO 13485:2016 certificated only in specific standard sections.

For example, a medical device manufacturer can still achieve ISO 13485:2016 certification despite not having Design and Development processes. The certificate will list the excluded sections that are not relevant to the manufacturer’s QMS.

Having ISO 13485:2016 certification allows companies to:

• Demonstrate compliance with regulatory requirements
• Ensure the establishment of QMS processes to manufacture safe and effective medical devices
• Demonstrate validated processes to manage risk effectively
• Gain a competitive advantage in the market

How To Be ISO 13485:2016 Certified?

Due to the complex certification process, this article will only provide a brief overview of how to become ISO 13485:2016 certified.

The first step is to choose a certification body. They audit medical device organizations and issue certificates proving that the QMS complies with the ISO 13485:2016 requirements.

Note that ISO is not involved in certification and does not issue certificates. So, it is important to check if the certification body uses relevant ISO’s Committee on Conformity Assessment (CASCO) standards and is nationally accredited to provide independent confirmation of competence.

You can contact your national accreditation body or visit the International Accreditation Forum (IAF) CertSearch to find an accredited certification body.

In the second step, the certification body evaluates medical device companies’ documents regarding the ISO 13485:2016 scope under which they wish to be certified in a Stage 1 audit.

If the certification body finds that the documents are compliant, it will conduct an on-site audit, also known as a Stage 2 audit.

Finally, the certification body will issue a certificate if the organization QMS complies with the ISO 13485:2016 requirements in the audited scopes.

Benefits of Being ISO 13485:2016 Certified

Here are some of the main benefits medical device organizations have from being ISO 13485:2016 certified.

Comply With Regulatory Requirements

If certified, you can prove compliance with a set of requirements of an international regulatory standard that reflects the QMS requirements of EU MDR and US FDA 21 CFR Part 820.

Attract New Customers

It improves the confidence of potential customers of your product when they acknowledge compliance and certification to the ISO 13485:2016 standard.

Become a Top Manufacturing Supplier

It is easier to be approved as a medical device manufacturing supplier since you can demonstrate validated quality processes.

Assess and Manage Risks Efficiently

The quality and safety of your medical devices are ensured through ISO 13485:2016 compliant processes being consistently followed by personnel. This way, non-conformances or risks can be detected and assessed more easily.

Improve Processes and Efficiency

By streamlining quality processes, you will reduce non-conformances and avoid rework, resulting in greater efficiency, cost savings, and ensuring continuous improvement.

Implement Evidence-Based Decision-Making

You are constantly provided with relevant and useful information from processes that help you make decisions in line with your goals.

The ISO 13485:2016 is a regulatory standard in the medical device industry. As mentioned above, it can speed up the MDR certification process regarding QMS requirements and might be aligned with FDA 21 CFR Part 820 in the future, adding even more benefits to achieving ISO 13485:2016 compliance and certification.

The Role of an eQMS in Supporting Compliance With the ISO 13485:2016 QMS Standard

Requirements for a QMS in the medical device industry are specified in the ISO 13485:2016. Companies can achieve compliance using paper-based, hybrid, or electronic QMS.

Small companies with sufficient resources can implement successful paper-based and hybrid QMS.

However, using a paper-based or hybrid QMS can present some challenges. Gathering all responsible personnel signatures can be time-consuming, and storing all the files requires a lot of physical space.

Implementing a digital solution to QMS is an important decision for a medical device company. With eQMS, you can easily streamline processes to save time and costs while improving efficiency.

SimplerQMS provides a complete eQMS software solution with all life science QMS modules. From document control and change control management to supplier management, audit management, and more.

SimplerQMS is a comprehensive eQMS platform that supports medical device companies achieving compliance with the ISO 13485:2016 while increasing efficiency and reducing costs.

If you are interested in identifying the value of an eQMS for your organization and presenting it to the decision-makers and stakeholders, download an eQMS business case template.

Frequently Asked Questions About ISO 13485:2016

What Is the Current Version of ISO 13485?

The current version of the ISO 13485 standard is the ISO 13485:2016, published in March 2016. It is the third edition of the ISO 13485 that cancels and replaces previous versions.

It also summarizes the changes incorporated into the latest version compared with the previous one in Annex A.

Where is ISO 13485:2016 Compliance Required?

Compliance with the ISO 13485:2016 is required by medical device companies involved in the manufacturing of medical devices and related services.

Additionally, QMS that complies with the ISO 13485:2016 can be presumed to conform with QMS requirements in EU MDR and can be aligned with FDA 21 CFR Part 820 in the future.

Does the FDA Accept Compliance with ISO 13485:2016 QMS Requirements?

The FDA does accept compliance with the ISO 13485:2016 via the Medical Device Single Audit Program (MDSAP) regarding QMS requirements.

MDSAP allows a single regulatory audit of a medical device manufacturer to be valid across all program members: Australia, Brazil, Canada, Japan, and the United States.

Additionally, in February 2022, the FDA issued a proposed rule to align the QMS regulation, 21 CFR Part 820, with the ISO 13485:2016 standard. However, due to COVID-19, the decision was delayed and will be analyzed soon.

Who Enforces ISO 13485:2016 QMS Requirements?

The ISO 13485:2016 was created and issued by the International Organization for Standardization (ISO). ISO is an independent, non-governmental international organization with a membership of standards bodies from 167 countries.

ISO does not provide certification or conformity assessment. Medical device organizations need to contact an external certification body to be certified.

Authorized third-party certification bodies enforce the ISO 13485:2016 QMS requirements through audits. The certification is valid for three years.

Once your organization has received the ISO 13485:2016 certification, you will be regularly audited to ensure your compliance, usually once a year. Recertification audits are required as the 3-year validity expires.

What Is the Difference Between ISO 13485:2016 And EN ISO 13485:2016?

Both the ISO 13485:2016 and the EN ISO 13485:2016 are the same word-by-word standard. However, the European EN version has the Z annexes to compare sections where compliance with the international ISO 13485:2016 fails to address EU requirements adequately.

What Is the Difference Between ISO 9001:2015 And ISO 13485:2016?

The main difference between ISO 9001:2015 and ISO 13485:2016 QMS requirements is that the first is the internationally accepted standard for organizations in any type of industry.

On the other hand, the ISO 13485:2016 specifically addresses QMS requirements for medical device organizations and is a regulatory standard.

Final Thoughts

Medical device organizations must have a robust QMS to comply with Life Science regulations and standards, ensuring safe and effective devices are placed on the market.

The ISO 13485:2016 is a regulatory standard for medical device QMS. Manufacturers that comply with this standard demonstrate the ability to provide devices and related services that consistently meet customer and applicable regulatory requirements.

Using paper-based and hybrid QMS presents challenges, such as human errors, lost documents, time-consuming audits, the need for physical storage, and so on.

An alternative to these is eQMS. A digital solution helps medical device manufacturers to secure and store data in a cloud-based system, and streamline quality processes.

SimplerQMS Software provides a robust eQMS that complies with the ISO 13485:2016. We offer a complete solution with all core QMS modules, including document control, change management, training, audit management, risk management, CAPA, non-conformance, supplier management, and more.

Request a demo of the SimplerQMS solution and talk with our experts about streamlining your quality management processes and making ISO 13485:2016 compliance easier.

The post ISO 13485:2016 Compliant QMS [Role of an eQMS] appeared first on SimplerQMS.

Upon doing some research online, you will come across the terminology “21 CFR Part 820 Quality System Regulation (QSR)”. Which is a set of regulations put in place by the US FDA that all medical device manufacturers must adhere to when they wish to sell their products in that country.

In this article, we will take a deep look at what 21 CFR Part 820 QSR is all about, its purpose, and requirements, and understand the role played by QMS software in supporting compliance with this important regulation.

Jump to:

• What is FDA 21 CFR Part 820?
• Purpose of FDA 21 CFR Part 820 Quality System Regulation (QSR)
• FDA 21 CFR Part 820 Quality System Regulation (QSR) Requirements
• Simplify 21 CFR Part 820 Compliance with a Medical Device QMS Software

What is FDA 21 CFR Part 820?

The FDA 21 CFR Part 820 is a set of regulations from the United States Food and Drug Administration (FDA) that emphasizes current good manufacturing practice (cGMP) requirements.

All medical device manufacturers must follow 21 CFR Part 820 when they manufacture and sell medical devices for the US market. With this, the company assures both the public and the regulatory agency that the medical devices are safe and efficacious.

Do note that 21 CFR Part 820 covers the entire gamut of a product’s lifecycle – from its design, manufacture, packaging, and labeling, to storage, installation, and servicing of all finished medical devices that are to be used by humans. This also includes the facilities and designs that will be used for these processes.

What Is the Difference Between ISO 13485:2016 and 21 CFR Part 820?

The main difference between ISO 13485:2016 and 21 CFR Part 820 is that while ISO 13485:2016 is a voluntary international QMS standard for medical device companies, 21 CFR Part 820 is a compulsory QMS regulation that is specific only to medical devices sold in the United States.

General differences between these two standards are given in the table below.

FDA 21 CFR Part 820 Amendment

The FDA is planning an amendment to 21 CFR Part 820, to align it more closely with ISO 13485:2016. This proposed regulation was published on 23 February 2022 and can be accessed here.

The Quality System Regulations (QSR) under 21 CFR Part 820, first brought out in 1978, were previously amended way back in 1996.

When finalized, the amendment will be a crucial step in the global harmonization of all medical device regulations. This harmonization will guarantee the removal of multiple regulatory requirements and impediments that are barriers to patient access to effective medical devices.

The new regulation will be titled Quality Management System Regulation (QMSR).

It will contain certain key elements of 21 CFR Part 820, including certain definitions, clarifying concepts, and additional requirements that will make sure that the new regulation continues to conform to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The latest version of ISO 13485 (namely ISO 13485:2016) will become a part of the proposed QMSR. Any future revisions to this ISO standard will only be incorporated if and when the FDA deems it necessary.

Recommended Reading: Medical Device Quality Management System (QMS)

Purpose of FDA 21 CFR Part 820 Quality System Regulation (QSR)

The purpose of the 21 CFR Part 820 (QSR) is to make sure that medical devices that have been created and developed for the US market are safe and efficacious. Medical device manufacturers must assure the regulatory agency (in this case the FDA) and the end-users that the products they manufacture are both effective, and safe for the intended purpose.

This regulation is mandatory, and any discrepancy or non-compliance can result in the FDA issuing Warning Letters, which will be shared with the public via the FDA website.

For instance, on November 4, 2022, the FDA issued a safety communication to warn parents, caregivers, and healthcare providers about unapproved infant head-shaping pillows that can result in an unsafe sleep environment.

FDA 21 CFR Part 820 Quality System Regulation (QSR) Requirements

As discussed earlier, the QMS requirements for any medical device company marketing in the US are given in 21 CFR Part 820 Quality System Regulation (QSR).

We will now look closely at the essential aspects that must be addressed by your company’s Quality Management System. Additionally, several examples are given to demonstrate how a modern electronic QMS (eQMS) can help you streamline these processes.

Subpart A – General Provisions

This section highlights the companies to whom this regulation applies, and relevant definitions, in accordance with the Federal Food, Drug, and Cosmetic Act.

This section clearly mentions that 21 CFR Part 820 is pertinent to all medical devices, either manufactured in the United States or imported and intended for use there.

Subpart B – Quality System Requirements

This section covers:

• Management responsibility
• Internal quality audits
• Personnel

Let’s look at each section in more detail.

Management Responsibility

This consists of rules and regulations about your company’s quality policies, resources, and planning.

• Quality Policy. Senior management of the company will commit to quality in accordance with 21 CFR Part 820. Ensure that all personnel within the company understand the requirements for such quality, and implement and sustain this quality.
• Organization. Senior management will establish and maintain a sufficient organizational structure. This means that they will provide appropriate responsibility and authority to key personnel for managing, performing, and assessing anything related to quality. Provide adequate resources including training. Appoint a key person who will supervise the quality system and provide feedback to the senior management at regular intervals.
• Management Review. At predefined intervals, management will review the effectiveness of the quality system. The entire process will be documented.
• Quality Planning. Your company should have a quality plan in place that will clearly elucidate the quality practices, activities, and resources that are relevant to the products that you design and manufacture.
• Quality System Procedures. The company will create protocols and procedures for the quality system.

It is crucial that you operate with a single source of truth that will ensure that decisions can be taken from data obtained from across the entire company. This is essential for compliance with regulatory commitments. One way of ensuring this is to have a centralized quality system that will act as the backbone of your quality management processes.

An eQMS software like SimplerQMS will enable you to have complete control over your quality data and documents, as well as simplify and automate most, if not all, of your quality processes. This will free up time for personnel to focus on other areas of the business while still maintaining compliance with 21 CFR Part 820.

Internal Quality Audits

Such audits are to be conducted by trained personnel who are not involved with a particular department/process. You will provide and conduct such quality audits to assure yourself that the quality system in the company is compliant with 21 CFR Part 820 QSR.

To be ready for audits, internal as well as external, you need to be able to have your documentation in order and ready to be retrieved at a moment’s notice to show the current state of compliance of your quality system.

This is where an eQMS with a built-in audit management module can help you.

By having all relevant documents in a central repository, you can save time and effort in retrieval, as well as have peace of mind knowing that you will not be caught off-guard during an audit.

Personnel

Your company must have experienced personnel to ensure that all quality-related activities are properly performed. When required, personnel are to be trained as per the requirements and such training must be documented.

When your medical device company has a high number of employees, and there are several branches located in different cities or countries, it becomes extremely difficult to manage and monitor the training of personnel.

An eQMS with a built-in training management module can automate and keep track of employee training, as well as maintain records of who has been trained on what (PDF documents, PowerPoint slides, videos, etc.), and when the training took place.

Furthermore, training-related KPI reports can be generated to provide visibility into the progress of employee training.

Subpart C – Design Controls

What is meant by design controls? To put it in simple terms, your medical device company must ensure that every step in the lifecycle of your products is following pre-defined processes and protocols.

Design controls apply to all Class II and Class III medical devices, and certain Class I devices.

The list of specific Class I medical devices includes:

• Tracheobronchial suction catheters
• Surgeon’s gloves
• Protective restraints, and so on
• As well as devices that are automated with computer software

As per this section of 21 CFR Part 820, you must have in place the following requirements:

• Design and Development Planning. You should have design and development plans for every medical device that you manufacture. These plans must be updated, reviewed, and approved when required.
• Design Input. Your company will ensure that the design of a particular medical device matches its intended use. Any incomplete, ambiguous, or conflicting requirements must be addressed. As with every other quality-related task, the design input requirements are documented, reviewed, and validated by authorized individuals.
• Design Output. You will establish and maintain suitable protocols to ensure that the design output will conform to the design input of every medical device that your company manufactures.
• Design Review. At suitable stages of a device’s design development, your company must have procedures for formal and documented reviews. The participant in these reviews will not only include concerned staff, but also staff without direct responsibility for that particular design stage, and specialists. The results will be documented in the Design History File (DHF).
• Design Verification. With design verification, you will have protocols that ensure that the design output conforms to the requirements of the design input.
• Design Validation: Your company will ensure that the devices, and their software, are compatible with their intended use. This will also include testing the production units via simulated or actual use conditions.
• Design Transfer. During this stage, you will ensure that the device design is properly translated into product specifications.
• Design Changes. You may wish to bring in some changes to the design of a medical device so that its efficiency and efficacy are improved. This is possible after review and approval at this stage.
• Design History File. The DHF for each type of medical device will show that the device was designed in agreement with approved design plans.

An eQMS software such as SimplerQMS can also help you manage design changes, as you will be able to track who made the change, when it was made, and why it was made.  This will help you to prevent unauthorized changes from being made, and ensure that all changes are properly documented, reviewed, and approved.

Furthermore, with SimplerQMS you can easily compile your DHF, DHR, or DMR by using the Document Collection Tool. Just search, filter, and make a “snapshot” of the current documentation for each product, which you can then export or share externally.

Recommended Reading: Design Controls for Medical Devices

Subpart D – Document Controls

A crucial aspect of your medical device company’s quality management system is document management.

This will include protocols for complying with document control as per 21 CFR Part 820 Subpart D, designating one or more personnel to review and approve documents and review changes as required. And, ensure that approved changes are communicated with required personnel in a timely fashion.

Furthermore, documents need to be named, numbered, and versioned, only the latest version must be circulated, and all older versions need to be archived.

SimplerQMS’s document controls offer an automated and streamlined way to manage documents and changes. With every change that is made, a new version is created automatically and all affected documents are updated accordingly. This ensures that everyone is always using the latest version of a document and that older versions are archived and easily accessible.

Recommended Reading

• Medical Device Document Control: What It Is & How to Simplify It
• Quality Management System Documentation [Best Practices]

Subpart E – Purchasing Controls

Purchasing controls are the management of your company’s supply chain and all third-party suppliers, contractors, and consultants.

You need to have in place all requirements, including quality requirements, which these third-party suppliers must meet before onboarding. You also need to define the type of control that you will have over the products or services provided.

And of course, you will need to document all records and documents and manage purchasing data.

Your company will need to define and document the procedures for qualifying suppliers, based on their ability to meet your quality requirements. As well as establish criteria for re-evaluating supplier performance.

SimplerQMS’s supplier quality management module is designed to help streamline and simplify your company’s supplier management processes. You can use it to manage your Approved Supplier Lists (ASLs), and other supplier-related documentation, monitor supplier performance, and track and approve changes.

This module integrates with the non-conformance and CAPA modules, so you can quickly and easily identify and address any issues that arise.

Recommended Reading: Medical Device Supplier Management Process (8 Steps)

Subpart F – Identification and Traceability

With identification procedures in place, you will ensure that there is no mix-up during the receipt, production, distribution, or installation of a medical device.

You should be able to identify every unit, lot, or batch of a finished device that is capable of causing considerable injury if it malfunctions.

Corrective actions must also be incorporated and documented in your Device History Record (DHR).

Document linking is a key function of QMS software solutions like SimplerQMS that ensures full traceability throughout your quality management system. With document linking, you can quickly and easily see the relationship between documents, and trace changes back to their source.

Subpart G – Production and Process Controls

With production and process controls, you will cover the inspection, measurement, test equipment, and process validation. You will also need to have protocols for corrective actions if required.

The company will also look into the following aspects:

• Environmental Controls. Any significant environmental conditions that can affect your product’s quality need to be controlled.
• Personnel. You will ensure that product quality is not compromised because of the health, cleanliness, personal practices, or clothing of your staff.
• Contamination Control. Ensure that all manufacturing equipment and products are sterile.
• Building. The buildings wherein the manufacturing processes take place must have sufficient space.
• Equipment. All manufacturing equipment must adhere to certain prerequisites. You will need to set schedules for maintenance and periodic inspections.
• Manufacturing Material. If there is reasonable doubt that a manufacturing material will adversely affect a product’s quality, such material must be discarded appropriately.
• Automated Processes. All computers and automated data processing systems that are part of the QMS or product production must be validated before use. Also, any changes in the software must have prior validation and approval. All validation activities and results need to be documented.

Subpart H – Acceptance Activities

Section H of 21 CFR Part 80 explains acceptance activities.

Your company’s QMS must provide details regarding:

• Protocols for inspection
• Tests
• Acceptance of incoming products
• In-process acceptance
• Acceptance of the finished product

Subpart I – Nonconforming Product

The company’s QMS must have procedures and protocols to identify whether products conform to acceptance criteria.

This conformance is not just with finished products but throughout the product’s lifecycle. It will include manufacturing, packaging, labeling, installation, and servicing.

For instance, you are not only responsible for the manufacture of the intraocular lens mentioned earlier, but also for its sterile packing, labeling, and distribution to your customers.

When a product does not conform to any aspect during its lifecycle, you will need to determine whether an investigation is necessary, and then proceed with the non-conformance.

When your company has a large portfolio of products and a big customer base, analyzing non-conformances becomes difficult.

QMS software with built-in non-conformance (NC) management capabilities can help automate and streamline the process of logging, analyzing, and investigating NCs by storing all relevant information in one central location. Pre-configured workflows and forms can also help ensure that investigations are conducted promptly and efficiently. KPI reports can provide valuable insights into areas where improvements are needed.

Recommended Reading

• What Is Non-Conformance And How to Minimize It
• What is a Non-Conformance Report in Life Sciences?

Subpart J – Corrective and Preventive Action (CAPA)

With Corrective Action and Preventive Action (CAPA), your medical device company will map out corrective and preventive actions for potential risks and errors.

Your QMS should cover all processes including audit findings, records, complaint handling, and returns.

For instance, if you identify a potential issue during an audit, you can take preventive action to ensure that the problem does not occur.

This could involve changing the design of your product, updating your quality control procedures, or implementing new safeguards in your manufacturing process.

CAPA management is a continuous process, and you will need to track all corrective and preventive actions to ensure that they are completed effectively.

CAPA management capabilities built into most eQMS solutions can help automate the CAPA process by providing pre-configured workflows and forms for logging, investigating, and taking corrective or preventive action. Plus, features like automated reminders, email notifications, escalation of open CAPAs, and KPI reports, can help ensure that CAPAs are addressed promptly and effectively.

Recommended Reading: What Is CAPA in the Medical Device Industry?

Subpart K – Labeling and Packaging Control

With this set of controls, you will ensure that the products that the company manufactures are labeled clearly and affixed properly.

You will not want customers to raise complaints about illegible labels, or for that matter, complain that they have received products without any labels! It would be equal if products are wrongly labeled.

Do have a proper set of procedures for the production and inspection of labels and packages!

Subpart L – Handling, Storage, Distribution, and Installation

Another important aspect that 21 CFR Part 820 emphasizes is that your company will ensure that mistakes do not occur when finished products are being handled, stored, distributed, or installed.

These are amongst the last steps in the long lifecycle of any medical device. You will definitely not want any problems to arise at this point in time.

This only goes to show the importance of quality throughout the lifecycle of every medical device.

Subpart M – Records

Your company will need to maintain and make available the following records during audits.

• Device Master Record (DMR). The DMR will contain pertinent information on each device and product specifications, including quality assurance procedures.
• Device History Record (DHR). The DHR will contain the dates on which a device was manufactured, the quantity manufactured, and the quantity released.
• Quality System Record. The QSR will detail the locations wherein procedures and activities are stored.
• Complaint Files. Whenever the company receives complaints regarding one of its products, the company will review, evaluate, and maintain them in complaint files.

Record maintenance is a critical aspect of quality management, and most QMS software solutions offer powerful features for managing such records.

Subpart N – Servicing

When a medical device that you manufacture needs servicing, you should provide detailed instructions for the same.

You need to keep records of the location of such servicing, the personnel carrying out the servicing, and details of what is done. The same holds good even if these activities are outsourced to a third party.

Subpart O – Statistical Techniques

Where required, your company will have procedures for identifying statistical techniques for process capability and product characteristics.

Considering that statistical techniques are crucial for the service reports in 21 CFR Part 820, you should have in place innovative statistical methodologies that will give you an advantage during clinical studies.

Simplify 21 CFR Part 820 Compliance with a Medical Device QMS Software

You will now have a fair idea of the requirements of 21 CFR Part 820 that your medical device company must comply with. You should also have realized by now that a medical device QMS software solution will be of great help in complying with these regulations.

A system that offers comprehensive features aligned with the requirements of 21 CFR Part 820 will help ensure compliance while also providing other benefits like shortening time to market, reducing costs, and improving customer satisfaction.

The best QMS software solutions on the market today offer a range of features that support compliance with 21 CFR Part 820.

SimplerQMS is one such solution. It is an all-in-one medical device quality management software that helps you with design control, document control, non-conformance, complaint, CAPA, training, supplier management, and much more.

Time-stamped audit trails, electronic signatures, pre-configured workflows, procedure, and form/template package are just some of the features that make compliance easier. Work with your documents using familiar Microsoft Office tools, and save your documents into the cloud-based system with a single click. No need to download and upload documents every time you need to work on them!

SimplerQMS provides a fully validated system according to GAMP5. It fully complies with ISO 13485:2016, 21 CFR Part 11 and 820, and the EU Annex 11 regarding validation and electronic signatures. Plus, we perform continuous re-validation so that you don’t have to.

If you are considering whether an investment in a quality management solution will be beneficial for your company, then we recommend you get our free eQMS Business Case template to calculate the economic impact of investing in a quality management solution, and present it to the management for approval.

Final Thoughts

When your medical device company wishes to manufacture and market in the United States, you must comply with the Food and Drug Administration’s 21 CFR Part 820, which emphasizes quality management.

Failure to comply with these requirements can result in serious penalties, including recalls, loss of market approval, and even criminal charges.

Traditional methods of compliance with 21 CFR Part 820 are paper-based and often involve maintaining physical files for different elements like design control, documents, training, change management, etc.

This can be extremely tedious and time-consuming. Moreover, it is easy to lose track of critical documents and records when they are in physical form.

A medical device QMS software solution can help you automate and streamline your quality management processes, and make it easier to comply with the 21 CFR Part 820 requirements.

SimplerQMS offers quality management software that offers a comprehensive suite of features to support compliance with 21 CFR Part 820. If you are interested in learning more about our software, schedule a demo with one of our quality solution specialists today!

The post 21 CFR Part 820 Quality System Regulation [Role of an eQMS] appeared first on SimplerQMS.

The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

When we look specifically at the Quality Management System (QMS) requirements, they are detailed in Article 10 (9) of EU MDR. For those companies familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, the resemblance with Article 10(9) will immediately stand out.

In this article, we will take an in-depth look at what EU MDR is all about, the main QMS requirements, as well as the role of QMS software in supporting compliance with EU MDR regulations.

If you are keen on learning more about how a medical device eQMS system such as SimplerQMS can help your organization streamline quality management processes, make compliance with EU MDR easier, and stay ahead of your competitors – book a demo and talk to one of our experts today.

But first, let us take a step back and look at the big picture.

• What is EU MDR?
• What is The Purpose of EU MDR?
• EU MDR QMS Requirements
• The Role of QMS Software in Supporting Compliance with EU MDR

What is EU MDR?

EU MDR stands for European Union Medical Device Regulations. It is a set of regulations governing both the production and distribution of medical devices in the European Union.

Medical device companies that plan to market their devices in the European Union, and require CE Marking, must comply with the regulations outlined in EU MDR.

Considering the importance of safety, quality, and efficacy of medical devices in the lives of end-users, the medical device industry must have in place an effective and efficient QMS. The EU MDR provides details for the overall responsibilities, procedures, and processes for Quality Management Systems.

As a medical device manufacturer, you will need to have a set of EU MDR-compliant systems, documents, and processes that will continually monitor the safety, efficacy, and efficiency of your products. These regulations are pertinent for medical device manufacturers, importers, distributors of medical devices into the EU, and authorized representatives of medical device companies.

EU MDR vs EU MDD

The EU Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the European Union. It was replaced by the new regulation, EU MDR that is intended to both improve the safety and performance of medical devices used in Europe and to provide an increased level of protection for patients and users of these devices.

EU MDR continues to have all the requirements mentioned in MDD, with the addition of some new requirements.

The key changes in EU MDR when compared to MDD are as follows.

Stricter Classification of Medical Devices

Medical device manufacturers, particularly those manufacturing devices that are to be used for surgeries, implantation, or other invasive procedures, including related software, must understand that the new classification of medical devices is now stricter.

For instance, medical devices that were under Class I of MDD will now come under Class 2a, at least.

MDR Annex VIII, Section 6 gives a comprehensive description of the new classification rules.

Furthermore, when the software drives a given medical device or plays a crucial role in the use of such a device, it will come under the same class as the device (refer to MDR Annex VIII, Chapter 2, Section 3.3).

Learn more about EU MDR medical device classification in our dedicated article.

Enhanced Traceability

EU MDR has introduced a Unique Device Identification (UDI) system that expedites easier traceability of medical devices.

This system aims to provide several benefits including:

• Reduction of medical errors
• Tracing falsified devices
• Improved purchasing and waste disposal
• Improved post-market safety-related activities and monitoring

The EU MDR’s Unique Device Identification (UDI) system is a distinctive numeric/alphanumeric code associated with a medical device. This UDI helps in the explicit identification of every device in the market. This facilitates their traceability.

Changes in the Quality Management System (QMS)

Under EU MDR regulations in Article 10, the scope of your medical device company’s QMS will now include protocols for clinically evaluating and operating a post-market surveillance (PMS) system.

Additionally, a post-market clinical follow-up (PMCF) is required for every product you manufacture.

Requirements for Notified Bodies

Annex VII (Requirements to be met by Notified Bodies) of EU MDR highlights requirements for the designation of Notified Bodies.

This means that every Notified Body must be set up in accordance with a member state’s national laws. Complete documentation should be available for the legality and the status of such a Notified Body.

These Notified Bodies must also provide information on their ownership.

Need for an Independent Expert Panel

When your company’s medical device comes under Classes IIa, IIb, or III, you will need to involve a Notified Body for conformity assessment. Notified Bodies are required to consult with expert panels before clearing certain high-risk devices.

This is obligatory when a Class III device is intended for implantation.

Improved Transparency

Under EU MDR regulations, information on all medical device products and tests is now in the public domain.

The European Electronic Database for Medical Device Information (EUDAMED) will provide a clear-cut picture of all devices that are available in the EU market.

This will help with transparency and assist coordination between the EU Member States.

Rigorous Clinical Evaluation Requirements

Clinical evaluation requirements are now tightened up under EU MDR regulations.

These include clinical data collection and the organization of clinical studies.

Implantable medical devices and Class III devices are required to undergo clinical trials before being marketed. For certain Class IIb and Class III devices that are used for drug management (within/outside the body), the medical device company has the option of consulting specified EU experts regarding a clinical development plan.

What is The Purpose of EU MDR?

The purpose of EU MDR regulations is to improve the safety and performance of medical devices used in the European Union. With the implementation of these regulations, your company and the regulatory agencies will ensure that there is enhanced protection for the end-users of your company’s medical devices.

When it comes to complying with EU MDR regulations, the use of traditional paper-based or hybrid QMS systems comes with its own set of challenges – storage, security, human errors, traceability, and costs, to name a few.

On the other hand, an electronic QMS made for medical devices such as SimplerQMS helps you manage and control all your quality processes in one place. From design and development to post-market surveillance, our medical device quality management software is equipped with the necessary tools and features to support your EU MDR compliance journey.

EU MDR QMS Requirements

As mentioned earlier, the QMS requirements for your medical device company are given in detail in Article 10 (9) of the current EU MDR.

Let us now deep dive into the indispensable aspects that your medical device quality management system (QMS) must address.

Throughout this section, you will also observe that various examples are provided showing how a modern electronic QMS will streamline these processes.

1. Regulatory Compliance

Your medical device company’s QMS must have a policy for regulatory compliance.

This means that you will adhere to the laws, regulations, guidelines, and specifications that are relevant to your industry.

For instance, the EU MDR clearly states that intra-ocular lenses come under Class IIb (Medium to High Risk). When your company is marketing these devices in the European market, you have to comply with the guidelines. You cannot market this product as Class IIa (Medium risk) or Class I (Low risk).

2. Conformity of Devices

Your medical device company should ensure that all devices that are in production conform.

According to this regulation, you have to maintain records and documents that show evidence that all products manufactured by your company exactly match the specifications, performance, and safety criteria applicable to that device.

If there are any changes, irrespective of changes in design or the harmonized standards must be attended to in a time-bound manner.

For instance, the intra-ocular lenses that you manufacture are made of silicone. Due to supply issues, you have decided to manufacture them out of acrylic, for which a 3rd party supplier is available. Such a change in the design must be immediately documented and the reasons explained.

By streamlining your quality management processes with modern QMS software with robust change management capabilities like SimplerQMS, you can easily keep track of all changes made to your products, devices, and processes.

Recommended Reading

• Medical Device Document Control: What It Is & How to Simplify It
• What is a Medical Device Technical File and How to Structure It?

3. Management Responsibility

According to EU MDR regulations, the senior management of your company should show commitment towards the development and implementation of an effective QMS in accordance with EU MDR.

What does this mean?

Your senior management must communicate with all employees the importance of the customer and regulatory requirements outlined in the regulations. Not only are you required to establish the company’s quality policy, but you must also establish the objectives, provide resources, and conduct reviews in a timely manner.

SimplerQMS software provides your company with a centralized repository that is a single source of truth for quality data. With this repository, you can manage all types of documents or files that will help you keep an overall check over the company’s QMS.

Moreover, this single source of data can be used for the creation of trending reports, such as CAPAs (open/closed), non-conformances (open/closed), training assignments (on time/overdue), and so on.

All this information will be most useful during your management reviews.

4. Resource Management and Control of Suppliers

Your QMS must include resource management methodologies, including information on selecting and control of suppliers and sub-contractors.

Your QMS must highlight the resources required for the effective implementation of EU MDR. These resources will be both human resources (trained and competent personnel) and infrastructure resources (equipment, space, information systems, and so on).

With the SimplerQMS software solution, you can ensure that all your suppliers are selected following pre-defined criteria. Furthermore, you will be able to make sure that your employees have received the proper training following current SOPs and quality protocols.

Recommended Reading: Medical Device Supplier Management Process (8 Steps)

5. Risk Management

Risk management is an essential component of EU MDR compliance.

All medical devices must be designed, manufactured, and packaged taking into account the purpose the device is intended for.

For instance, the intra-ocular lens we spoke about earlier must be packaged in such a manner that its sterility is maintained. You will not want the lens to inadvertently cause any infection because of a lack of sterility at your end.

A modern QMS software solution should be able to help you accelerate the development of your medical devices, including the processes of verification, validation, and design transfer. All the necessary documentation concerning product realization and risk management would be stored in a centralized repository and easily accessed via highly customizable dashboards.

Recommended Reading: Design Controls for Medical Devices

6. Clinical Evaluation Data and Post-Market Clinical Follow-Up

This is a systematic and planned process by which your company will assess the safety and performance of every medical device that you manufacture and market.

The chief intent of this aspect of EU MDR QMS is to exhibit conformity with the General Safety and Performance Requirements (GSPRs). GSPRs are listed in Annex I of EU MDR and include the intended purpose of the medical device, patient safety, risk control, device properties, and others.

For instance, the intra-ocular lenses that you manufacture are meant to be safe and efficacious for your customers. An unfortunate series of incidents take place wherein these lenses result in adverse events. You are obliged to find out the reasons and ensure that they do not repeat.

With a modern QMS software solution like SimplerQMS, you will be able to continuously collect and monitor data generated from every medical device that is placed on the market. The data may be, for example, in the form of customer complaints, non-conformances, or adverse event reports.

7. Upholding UDI Standards

Your medical device company’s quality management system must be able to make sure that the UDI for all your devices is verifiable, and you should also be able to ensure consistency and validity.

It goes without saying that spurious medical devices will play havoc with the lives of patients. It is also true that such devices are likely to be labeled with the details of a genuine company, which will then get into the crosshairs of regulatory agencies.

How do you safeguard your medical devices?

This is possible with the Unique Device Identification (UDI) for every medical device that you manufacture and market. As mentioned previously, the EU MDR’s UDI system provides exclusive numeric/alphanumeric codes for every authentic medical device in the market. This will help trace each and every medical device.

8. Communication Protocols

How well you communicate with competent authorities, Notified Bodies, customers, and other stakeholders will reflect on your QMS.

For instance, you should be sure of the regulatory needs for every medical device that your company manufactures, and engage a Notified Body as required. When your regulatory affairs department does it efficiently, you will be meeting the requirements and expectations of the Notified Body.

Annex VII of the EU MDR refers to requirements to be met by Notified Bodies.

The NANDO (New Approach Notified and Designated Organizations) database contains the list of notified bodies, their identification number, contact details, and the tasks for which they have been notified, including medical device CE marking.

9. CAPA Management

Your QMS system should have processes and protocols in place for managing corrective actions and the verification of their effectiveness.

Let us take for instance the intra-ocular lenses that you market in the European Union. Your Quality Department has received complaints from two locations that the sterility of some of these lenses is compromised. This is a serious issue that must be investigated with full vigor and CAPA generated.

With the CAPA management solution built into QMS software like SimplerQMS, you are assured of more streamlined CAPA management processes. You will be able to recognize and initiate CAPAs, recognize trends, conduct a root cause analysis, initiate actions, as well as verify and close the case with ease.

Recommended Reading: What Is CAPA in the Medical Device Industry?

The Role of QMS Software in Supporting Compliance with EU MDR

When you consider all the EU MDR requirements that were elaborated on in the previous section, you will realize that a traditional paper-based documentation system or a hybrid system will not suffice. They have their own set of challenges, including issues of human error, security, safety, storage, and the burgeoning costs of paper, files, printing, and so on…

Considering the importance of compliance with EU MDR regulations, your company, just like many other medical device companies nowadays should opt for a modern electronic QMS software solution.

With such a quality management solution in place, you will have all the provisions for maintaining compliance with EU MDR, streamlining your operations, increasing efficiency, lowering costs, and being able to confidently market your products in the European Union.

The best QMS software solutions on the market will offer you comprehensive and robust modules for document control, change management, training management, CAPA management, customer complaints, audits, and much more.

Centralized, cloud-based QMS solutions will offer you even more benefits with their anytime, anywhere access, automatic updates, and the ability to integrate with other enterprise software solutions.

Furthermore, features like, automated document routing, document versioning, version control, electronic signatures, time-stamped audit trails, access controls, and permissions will all contribute to the success of your compliance with various regulatory standards and guidelines.

Medical device QMS software by SimplerQMS is an excellent example of such a solution that offers you all the features and benefits that we have elaborated on.

SimplerQMS is a modern, cloud-based quality management software that helps companies in various industries streamline their operations and remain compliant with multiple standards and guidelines, including the EU MDR.

If you would like to assess whether investing in a quality management software solution is the best course of action for your company, then we suggest you download our eQMS Business Case template. It helps quantify the value of investing in quality management software for your business, and present it to decision-makers in your company.

Final Thoughts

Medical device companies are amongst the most highly regulated in the life science industry. This is essential considering that medical devices play such a huge role in the lives of patients.

If your medical device company wants to manufacture and market in the EU, you must be compliant with the EU MDR guidelines which have replaced the EU MDD with effect from 26 May 2021.

When you look specifically at the QMS requirements for medical device companies, you must be thorough with Article 10 (9) of EU MDR.

Traditional paper-based or hybrid QMS systems have no place in modern organizations because of their inherent difficulties and challenges. If you are keen on investing in an eQMS solution to streamline your QMS processes and make compliance with EU MDR easier, book a demo of SimplerQMS and talk to our quality solution experts today.

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