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.

FDA 21 CFR Part 11 specifies the regulatory requirements used in Food and Drug Administration (FDA) regulated industries for electronic records and signatures.

It outlines the requirements that companies must comply with to ensure the integrity, authenticity, and confidentiality of electronic records and signatures.

In response to the common questions and concerns surrounding FDA 21 CFR Part 11, we have compiled a list of the most frequently asked questions about the regulation. This article provides clear and concise answers to help you better understand what 21 CFR Part 11 entails.

Compliance with 21 CFR Part 11 is essential for companies using electronic records and signatures in FDA-regulated industries.

Life Science companies are now widely embracing 21 CFR Part 11 compliant solutions to effectively manage regulated processes and ensure rigorous compliance. One solution these companies utilize is eQMS software.

SimplerQMS provides an eQMS software compliant with 21 CFR Part 11 and designed specifically for Life Science companies. You can talk to our quality experts and book a personalized demo to learn how SimplerQMS can help your company work more efficiently and ensure compliance.

Table of Contents:

• What Is FDA 21 CFR Part 11?
• What Is the Main Purpose of the FDA 21 CFR Part 11?
• What Are the Main Benefits of 21 CFR Part 11?
• Who Needs to Comply With 21 CFR Part 11?
• When Does 21 CFR Part 11 Apply?
• What Are the FDA Electronic Records Predicate Rules?
• What Is FDA 21 CFR Part 11 Compliance?
• How To Be 21 CFR Part 11 Compliant?
• What Makes a Computer System 21 CFR Part 11 Compliant?
• What Are the Three Primary Areas of 21 CFR Part 11?
• What Are 21 CFR Part 11 Requirements?
• What Is an Electronic Record Under 21 CFR Part 11?
• What Are 21 CFR Part 11 Requirements for Electronic Records?
• What Is the Difference Between Open and Closed Systems in 21 CFR Part 11?
• What Is Computer System Validation According to 21 CFR Part 11?
• What Approach Is Recommended for Validating Electronic Systems?
• What Does Accurate Record Generation Mean?
• What Does Limited System Access Mean?
• What Is an Audit Trail Under 21 CFR Part 11?
• What Are 21 CFR Part 11 Requirements for Audit Trails?
• What Are Operational System Checks According to 21 CFR Part 11?
• What Are Device Checks According to 21 CFR Part 11?
• What Training Requirements Are Required for 21 CFR Part 11 Compliance?
• What Is a Policy of Responsibility for Using Electronic Signatures?
• What Documentation Requirements Apply to 21 CFR Part 11 Compliant Systems?
• What Is an Electronic Signature Under 21 CFR Part 11?
• If I Have Electronic Signatures, Do I Need To Comply With Electronic Record Requirements?
• What Are 21 CFR Part 11 Requirements for Passwords and Identification Codes?
• How Can I Identify if a System Is Compliant With 21 CFR Part 11?
• What Is the Difference Between the FDA 21 CFR Part 11 and EU Annex 11?
• What Is the Difference Between the FDA 21 CFR Part 11 and ISPE GAMP5?
• How Does SimplerQMS Help Comply With 21 CFR Part 11?

What Is FDA 21 CFR Part 11?

21 CFR Part 11 is part of a regulation by the FDA governing electronic records and signatures.

It outlines requirements for ensuring the reliability, authenticity, and integrity of electronic records and signatures used in FDA-regulated industries.

The initial publication of 21 CFR Part 11 occurred on March 20, 1997, and has been in effect since August 20, 1997. The most recent change to the regulation, as of July 2023, was made on March 2, 2023.

What Is the Main Purpose of the FDA 21 CFR Part 11?

The main purpose of 21 CFR Part 11 is to ensure the trustworthiness and reliability of electronic records and electronic signatures equivalent to traditional paper records and handwritten signatures.

The 21 CFR Part 11 establishes requirements to ensure data integrity, security, and reliability in electronic records and signatures to achieve its aim.

What Are the Main Benefits of 21 CFR Part 11?

Implementing 21 CFR Part 11 provides several main benefits, which include:

• Improved Data Integrity: The regulation ensures the accuracy, completeness, and reliability of electronic records, reducing the risk of errors and data inconsistencies.
• Regulatory Compliance: Following the requirements of 21 CFR Part 11 helps companies meet FDA regulations, demonstrating their commitment to data integrity, security, and reliability.
• More Efficient Workflow Processes: Electronic records and signatures enable streamlined and automated processes, reducing the reliance on manual paperwork and improving efficiency.
• Streamlined Collaboration: Electronic systems facilitate data sharing across teams, departments, and sites, enabling faster decision-making and smoother workflows.
• Improved Auditability: The requirements for audit trails and electronic signatures improve the auditability of electronic records, making it easier to track and review actions taken.
• Increased Security: 21 CFR Part 11 outlines the implementation of robust security measures, such as user authentication, access controls, and data encryption, ensuring the confidentiality, integrity, and availability of electronic records.
• Simplified Recordkeeping: Electronic recordkeeping eliminates the need for physical storage space and reduces administrative burdens associated with manual recordkeeping, allowing for more efficient and organized data management.

Who Needs to Comply With 21 CFR Part 11?

Companies operating in FDA-regulated industries that use electronic records and electronic signatures must comply with 21 CFR Part 11.

In the Life Sciences, this includes but is not limited to pharmaceutical companies, biotechnology firms, medical device manufacturers, clinical laboratories, and others involved in developing, manufacturing, testing, or distributing FDA-regulated products.

When Does 21 CFR Part 11 Apply?

21 CFR Part 11 applies whenever electronic records and signatures are used and managed for activities subject to FDA regulations.

It applies to a range of FDA-regulated activities within the pharmaceutical, biotechnology, medical device, and related industries, including different stages of product development, such as research and development, manufacturing, and distribution.

Would you like to assess whether you need to comply with the regulation? You can use the 21 CFR Part 11 applicability assessment to determine if your system for managing electronic records and signatures needs to comply with the 21 CFR Part 11 requirements.

What Are the FDA Electronic Records Predicate Rules?

Electronic records predicate rules are requirements outlined in the Federal Food, Drug, and Cosmetic Act (the Act), Public Health Service Act (the PHS Act), and FDA regulations, other than 21 CFR Part 11, regarding electronic records, electronic signatures, and computer systems.

Companies using electronic records, signatures, or systems as per one of the predicate rules, such as 21 CFR Part 210, 211, and 820, must also comply with the requirements of FDA 21 CFR Part 11.

What Is FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 compliance refers to acting following the requirements outlined in 21 CFR Part 11.

Compliance involves implementing the necessary controls and procedures to ensure the integrity, authenticity, and reliability of electronic records and signatures, as well as meeting security and data management requirements.

A compliant system helps avoid common noncompliances with 21 CFR Part 11 and potential regulatory and administrative actions from the FDA and US court, such as monetary penalties and product seizure.

Interested in learning the key steps to achieve compliance?

Find everything you need to know about 21 CFR Part 11 compliance in our article.

How To Be 21 CFR Part 11 Compliant?

To be compliant with 21 CFR Part 11, companies must fulfill the requirements outlined in the part of a regulation.

One effective approach is implementing compliant software eQMS solutions designed to streamline quality management processes and help ensure compliance with the FDA 21 CFR Part 11.

To assess the implementation of the 21 CFR Part 11, you can use a 21 CFR Part 11 compliance checklist.

What Makes a Computer System 21 CFR Part 11 Compliant?

A 21 CFR Part 11 compliant system should be able to ensure data integrity, security, and confidentiality of electronic records and signatures, while also providing compliance with the requirements outlined in 21 CFR Part 11.

Compliant system capabilities include, but are not limited to:

• Detecting any invalid or altered records.
• Generating accurate and complete copies of records in both human-readable and electronic formats.
• Enabling accurate retrieval of records throughout the retention period.
• Limiting system access to only authorized individuals.
• Implementing secure and time-stamped audit trails.
• Linking signatures to electronic records.
• Issuing unique identification codes and passwords.
• Enabling backup and recovery of data in the event of a system failure.

There is also confusion between 21 CFR Part 11 “compliant” and 21 CFR Part 11 “ready” systems, which are distinct states.

21 CFR Part 11 ready refers to a system with features aligning with 21 CFR Part 11 but may need configuration or validation for full compliance.

On the other hand, a 21 CFR Part 11 compliant system means the system has undergone validation and meets the regulation’s requirements. This makes it suitable for FDA-regulated environments without additional modifications.

What Are the Three Primary Areas of 21 CFR Part 11?

The three primary areas of 21 CFR Part 11 are categorized into subparts A, B, and C, which are as follows:

Subpart A – General Provisions: Define 21 CFR Part 11’s scope and applicability and provide key definitions for terms used throughout the regulation.

Subpart B – Electronic Records: Specify requirements for creating, modifying, and maintaining electronic records. It includes controls and procedures for ensuring data security, implementing audit trails, and limiting system access.

Subpart C – Electronic Signatures: Specifically addresses the use of electronic signatures. It outlines the requirements for their proper use, including controls for identification codes and passwords.

What Are 21 CFR Part 11 Requirements?

21 CFR Part 11 requirements include the controls and procedures to ensure the authenticity, integrity, and confidentiality of electronic records and prevent the signer from easily denying the legitimacy of the signed record.

In a brief overview, the 21 CFR Part 11 requirements are the following:

• 21 CFR 11.1: Scope of regulation
• 21 CFR 11.2: Implementation
• 21 CFR 11.3: Definitions of terms
• 21 CFR 11.10: Controls for closed systems
• 21 CFR 11.30: Controls for open systems
• 21 CFR 11.50: Signature manifestations
• 21 CFR 11.70: Signature and record linking
• 21 CFR 11.100: General electronic signatures requirements
• 21 CFR 11.200: Electronic signature components and controls
• 21 CFR 11.300: Controls for identification codes and passwords

You can learn more about the requirements outlined in the regulation in our dedicated article about the 21 CFR Part 11 requirements.

What Is an Electronic Record Under 21 CFR Part 11?

An electronic record under 21 CFR Part 11 is any digital information managed and processed electronically within the scope of 21 CFR Part 11.

It includes a combination of text, graphics, data, audio, pictorial, or other information created, modified, maintained, archived, retrieved, or distributed by a computer system as per 21 CFR 11.3(b)(6).

In addition to text documents, the following information assets are also included:

• Images
• Sound files
• Videos
• Test records
• Source code
• Spreadsheets

What Are 21 CFR Part 11 Requirements for Electronic Records?

21 CFR Part 11 requirements for electronic records are the procedures and controls Life Science companies must employ to ensure the authenticity and integrity of records.

All the requirements for electronic records are outlined in Subpart B of 21 CFR Part 11.

Subpart B includes requirements such as system validation, record generation, system access control, audit trails, operational checks, device checks, system user training, system documentation, signatures and records linking, signatures information, and more.

Want to dive deeper into the specific requirements? Read more about it in our article about 21 CFR Part 11 compliant electronic records.

What Is the Difference Between Open and Closed Systems in 21 CFR Part 11?

The difference between open and closed systems in 21 CFR Part 11 is the level of control over system access.

A closed system refers to an environment where access to the system is controlled by individuals responsible for its electronic records.

An open system refers to an environment where system access is not controlled by individuals who are responsible for the content of electronic records. In such systems, there may be less control over who can access the system and change the electronic records.

The difference between open and closed systems is important as it defines additional security measures to ensure compliance with 21 CFR Part 11 requirements.

What Is Computer System Validation According to 21 CFR Part 11?

Computer system validation is a process used to ensure that a computer system meets its intended use and complies with all applicable regulations.

It ensures the authenticity, integrity, and, when appropriate, confidentiality of electronic records, according to 21 CFR 11.10(a). Ensuring the ability to detect invalid or altered records is also essential.

21 CFR Part 11 outlines that computer system validation is necessary every time such systems are implemented or modified. It is required for computerized systems that are used to create, modify, maintain, or transmit electronic records or signatures subject to FDA regulations.

What Approach Is Recommended for Validating Electronic Systems?

The recommended approach for validating electronic systems is risk-based as outlined by industry guidelines such as ISPE GAMP5.

This means that the validation activities are prioritized based on the system’s risk and impact on product quality, data integrity, and patient safety. By conducting a thorough risk assessment, companies can identify critical functionalities and potential vulnerabilities.

What Does Accurate Record Generation Mean?

Accurate record generation refers to the 21 CFR 11.10(b) requirement that electronic records are created in a manner that ensures their accuracy and reliability, ensuring data integrity.

It means that the generated records should faithfully represent the information they are intended to capture without any intentional or unintentional alterations or discrepancies.

What Does Limited System Access Mean?

Limited system access means that access to computer systems used for electronic recordkeeping should be restricted to authorized individuals only.

Appropriate controls and procedures should be in place to prevent unauthorized access, ensuring that only authorized personnel can create, modify, or access electronic records as per 21 CFR 11.10(d).

Enforcing limited access for users involves implementing various measures to ensure that only authorized individuals can access computer systems used for electronic recordkeeping.

You can enforce limited access for users according to 21 CFR Part 11 by implementing the following methods:

• Unique identification codes and passwords
• Role-based access control
• Multifactor authorization
• Transaction safeguards to prevent unauthorized use of codes and passwords
• Verify the identity of the users

What Is an Audit Trail Under 21 CFR Part 11?

An audit trail under 21 CFR Part 11 is a secure, computer-generated, time-stamped record that captures and documents all user actions and system activities related to creating, modifying, or deleting electronic records.

It serves as a reliable source of information for tracking and verifying the integrity and authenticity of electronic records throughout their lifecycle.

What Are 21 CFR Part 11 Requirements for Audit Trails?

The requirements for audit trails are as follows according to 21 CFR 11.10(e):

• Secure and protected from unauthorized access.
• Computer-generated.
• Time-stamped.
• Contain information about who made changes to the electronic records, what changes were made, and when.
• Retained for at least as long as required for the corresponding electronic records.
• Readily available for FDA review and copying.
• Not obscure previously recorded information.

Looking for more information on audit trails? Check out our dedicated article about the audit trail requirements in 21 CFR Part 11.

What Are Operational System Checks According to 21 CFR Part 11?

Operational system checks refer to measures implemented within electronic systems to enforce the proper sequencing of steps and events according to 21 CFR 11.10(f).

These checks help ensure that operations are performed in the intended order and that any deviations or unauthorized actions are detected and addressed promptly.

What Are Device Checks According to 21 CFR Part 11?

Device checks are procedures implemented to verify the validity and reliability of data input sources or operational instruction in electronic systems, as defined by 21 CFR 11.10(h).

These checks assess the integrity of the devices, such as terminals, used to interact with the system. By conducting device checks, companies can ensure that the data entered, or instructions provided through the devices are accurate and appropriate for the intended operations.

What Training Requirements Are Required for 21 CFR Part 11 Compliance?

Training requirements required for 21 CFR Part 11 compliance specify that individuals who use electronic record and signature systems have the appropriate education, training, and experience to perform their assigned tasks according to 21 CFR 11.10(i).

Training records are documented proof of the training conducted in a company. These records are subject to the same requirements as any electronic record within the scope of 21 CFR Part 11 and are subject to the same controls.

You can learn more about the requirements for training records according to 21 CFR Part 11 by reading our article.

What Is a Policy of Responsibility for Using Electronic Signatures?

A policy of responsibility for using electronic signatures refers to a written document outlining the rules and guidelines regarding using electronic signatures within a company as per 21 CFR 11.10(j).

It holds individuals accountable and responsible for their actions initiated under their electronic signatures, preventing record and signature falsification.

The written document can be an Electronic Signature Agreement, signed by all users, indicating their acceptance and acknowledgment that their electronic signature carries the same legal weight as a handwritten signature.

What Documentation Requirements Apply to 21 CFR Part 11 Compliant Systems?

21 CFR Part 11 compliant systems should follow documentation requirements according to 21 CFR 11.10(k).

Documentation system requirements involve controlling the distribution, access, and use of system documentation for operation and maintenance purposes.

It also includes implementing revision and change control procedures that maintain an audit trail documenting the chronological development and modification of the system documentation.

What Is an Electronic Signature Under 21 CFR Part 11?

An electronic signature under 21 CFR Part 11 refers to a computer data collection of symbols executed and authorized by an individual.

The electronic signature is considered legally binding and is equivalent to the individual’s handwritten signature, according to 21 CFR 11.3(b)(7).

Electronic signatures are different from digital signatures.

Digital signatures are a type of electronic signature based on cryptographic methods to improve security as per 21 CFR 11.3(b)(5).

To learn more about key requirements, benefits, and best practices for 21 CFR Part 11 compliant electronic signatures see our comprehensive article on this topic.

If I Have Electronic Signatures, Do I Need To Comply With Electronic Record Requirements?

Yes, if you have electronic signatures being used to sign electronic records within an FDA-regulated industry, you must comply with the electronic record requirements outlined in 21 CFR Part 11.

Compliance with electronic records and signature requirements is necessary to ensure records’ integrity, authenticity, and reliability.

What Are 21 CFR Part 11 Requirements for Passwords and Identification Codes?

The requirements for passwords and identification codes outline controls to ensure electronic signatures’ security and integrity as per 21 CFR 11.300.

The requirements for passwords and identification codes include the following:

• Implement unique password and identification code combinations for each individual.
• Periodically check and revise password and identification codes to prevent password aging.
• Follow loss management procedures to deauthorize lost or stolen devices with password and identification codes. Issue replacements using suitable and rigorous controls.
• Use transaction safeguards to prevent unauthorized use of passwords and identification codes. Detect and report unauthorized use attempts to the system security unit and organizational management.
• Periodically test devices that use or generate passwords and identification codes to ensure they function as intended.

You can see our dedicated article about 21 CFR Part 11 password requirements to explore the requirements in greater detail.

How Can I Identify if a System Is Compliant With 21 CFR Part 11?

To identify if a system complies with 21 CFR Part 11, you can request the software vendor provide proof of compliance. The vendor should be able to provide you with documentation that their system has been tested and is compliant with 21 CFR Part 11 requirements.

A vendor should undertake several actions and provide evidence to support their claim. Here are some proof of compliance you can ask the vendor to provide:

• Documentation that the system has been validated, including test procedures and the results of the tests.
• Information on the system access and security controls to protect the integrity and confidentiality of electronic records and signatures.
• Security procedures for responding to incidents, including procedures for reporting incidents, investigating them, and taking corrective action.
• Records of audits or inspections conducted to ensure compliance with 21 CFR Part 11.

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

The difference between FDA 21 CFR Part 11 and EU Annex 11 are the jurisdiction they apply to and their regulatory status.

FDA 21 CFR Part 11 is specific to the United States and applies to all FDA-regulated industries, including pharmaceuticals, medical devices, and biotechnology. It provides detailed requirements for electronic records and signatures. Compliance with 21 CFR Part 11 is mandatory for companies performing FDA-regulated activities.

On the other hand, EU Annex 11, is part of the European Union’s Good Manufacturing Practice (GMP) guidelines and applies to manufacturers of medicinal products within the EU member states. It focuses specifically on computerized systems used in GMP-regulated environments. Since EU Annex 11 is a guideline, compliance is optional.

You can learn more about the specific differences between FDA 21 CFR Part 11 and EU Annex 11 by reading our dedicated article on the topic.

What Is the Difference Between the FDA 21 CFR Part 11 and ISPE GAMP5?

The difference between FDA 21 CFR Part 11 and ISPE GAMP5 is their regulatory status and purpose.

FDA 21 CFR Part 11 is a part of regulation specific to the United States that outlines requirements for electronic records and signatures in FDA-regulated industries.

ISPE GAMP5 is an international guidance document that provides a risk-based approach for the validation of computerized systems.

How Does SimplerQMS Help Comply With 21 CFR Part 11?

SimplerQMS helps Life Science companies to achieve 21 CFR Part 11 compliance by providing a comprehensive eQMS software solution that facilitates the management of electronic records, signatures, and quality documentation.

Here are some key features and functionalities of SimplerQMS that align with 21 CFR Part 11 requirements:

• Validated System: SimplerQMS is fully validated according to ISPE GAMP5 and undergoes revalidation when new versions or updates are released, eliminating the need for additional validation resources from our clients.
• Secure Data Storage and Retrieval: We offer secure cloud storage for records, ensuring documents are protected and readily available during audits. A search feature allows for easy record retrieval based on keywords in titles and content.
• Limited System Access: SimplerQMS connects with Microsoft Entra ID (previously known as Microsoft Azure Active Directory), enabling secure authentication and authorization and limiting system access to verified and authorized personnel.
• Time-Stamped Audit Trail: The software provides a comprehensive and accurate audit trail that tracks all system activity, including record access, modifications, and approvals, as well as enabling easy comparison of changes and rollback to previous versions if needed.
• Employee Training: We provide personalized training sessions support to ensure all system users know how to do their assigned tasks in SimplerQMS.
• Electronic Signatures: The software offers out-of-the-box 21 CFR Part 11 compliant electronic signatures. Signatures are automatically linked to their respective records, ensuring authenticity and integrity.

Our platform supports compliance with various Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, and 820, EU GMP Annex 11, EU GMP, and more. With our extensive QMS process support, SimplerQMS software helps companies comply with the necessary standards and regulations.

Some of the QMS process support that the SimplerQMS solution offers includes document management, employee training, change control, CAPA management, complaint management, audit management, supplier management, and more.

If you are interested in identifying the value of an eQMS for your company, download our eQMS Business Case template.

The template allows you to assess the benefits of an eQMS tailored to your needs and present a well-rounded analysis to management.

By using this resource, you can ensure that all critical factors are considered and effectively demonstrate the advantages of implementing an eQMS.

Final Thoughts

FDA-regulated industries must comply with 21 CFR Part 11, a part of the regulation governing electronic records and signatures. Many companies have questions regarding compliance and understanding the intricacies of the regulation.

In this article, we addressed frequently asked questions to help you gain a better understanding of 21 CFR Part 11, providing insights and guidance to clarify any doubts you may have.

SimplerQMS provides an eQMS solution fully compliant with 21 CFR Part 11 and validated according to ISPE GAMP5. Our system is designed to assist Life Science companies in meeting various compliance requirements.

To discover how SimplerQMS can improve your quality management and compliance efforts, schedule a demo, and talk with our quality experts today.

The post What is FDA 21 CFR Part 11? (32 Questions and Answers) appeared first on SimplerQMS.

By conducting the applicability assessment, Life Science companies can identify the specific 21 CFR Part 11 system controls necessary to ensure compliance. These controls encompass several procedures related to electronic records and electronic signatures.

This article provides an overview of the 21 CFR Part 11 applicability assessment and its steps. We will discuss how to determine the need for validation and effectively conduct and conclude the applicability assessment process.

Additionally, we will explore the role of compliant software solutions in achieving 21 CFR Part 11 compliance.

SimplerQMS provides fully 21 CFR Part 11-compliant eQMS software designed specifically for Life Science companies. Book a personalized demo and talk with our experts to learn how SimplerQMS can help you implement a QMS that reflects your compliance requirements.

This article covers the following topics in more detail:

• What is the 21 CFR Part 11 Applicability Assessment?
• 21 CFR Part 11 Applicability Assessment Steps
• Role of 21 CFR Part 11 Compliant Software

What is the 21 CFR Part 11 Applicability Assessment?

The 21 CFR Part 11 applicability assessment is a process used to determine whether a computerized system, which is used for managing electronic records and electronic signatures, falls under the requirements of 21 CFR Part 11 and specifically identifies which requirements are applicable.

The 21 CFR Part 11 requirements establish measures to ensure the trustworthiness, reliability, and equivalence of electronic records, electronic signatures, and handwritten signatures on electronic records to their paper counterparts.

The assessment provides a documented rationale for determining the need for particular controls and procedures to ensure compliance with specific parts of 21 CFR Part 11.

21 CFR Part 11 Applicability Assessment Steps

The 21 CFR Part 11 applicability assessment involves systematic steps to determine which compliance requirements apply to the electronic system.

Firstly, Life Science companies should define whether validation is required by evaluating if the system’s functions fall under the scope of applicable requirements.

Once validation requirements are determined, the assessment moves on to conduct a detailed evaluation, examining the system’s controls that may be needed concerning electronic records and signatures.

Finally, the assessment concludes by determining the minimum applicable 21 CFR Part 11 requirements and documenting the assessment findings.

At SimplerQMS, we utilize the Regulatory Criticality Assessment (RCA) as our 21 CFR Part 11 applicability assessment. The RCA Decision Pathway outlines the key questions that companies must address to determine what 21 CFR Part 11 controls may be needed.

Below is a simplified version of the 21 CFR Part 11 applicability assessment decision pathway.

Determine If Computer System Validation is Required

Computer system validation is required if processes within the company are regulated by any GxP regulations, FDA 21 CFR Part 11 and 820, and ISO 13485:2016.

Validation is necessary if these regulated processes involve controlled and documented electronic systems activities.

SimplerQMS provides a QMS software fully validated according to ISPE GAMP5 following a risk-based approach to computerized systems.

Our software is always maintained in a validated state. With each new version and standard update, we validate the system, saving you from the hassle of conducting validation activities yourself.

With SimplerQMS, you can eliminate additional costs, resource requirements, and time commitments associated with QMS software validation. We handle all the validation work, allowing you to focus on the core competencies of your Life Science company.

Conduct 21 CFR Part 11 Electronic Records Assessment

The 21 CFR Part 11 electronic records assessment determines if the system uses electronic records and the necessary controls and procedures to be implemented.

To properly evaluate the system, it is essential to determine if it serves the following purposes:

• Does the system store electronic records?
• Is the system of minor significance in creating records, performing simple data entry, or maintaining transient data?
• Is the system solely utilized for generating paper printouts of electronic records?
• Does the system rely on the internet or other open systems where the company does not control all system components?

Conclude on 21 CFR Part 11 Electronic Records Assessment

The conclusions of the 21 CFR Part 11 electronic records assessment are based on the system functions determined through the responses to the assessment questions above.

If the system stores electronic records, requires validation, and is a closed system, it must comply with the minimum requirements for electronic records outlined in 21 CFR Part 11.10.

The 21 CFR Part 11 requirements for electronic records are:

• 21 CFR 11.10(a): System validation.
• 21 CFR 11.10(b): Ability to generate accurate and complete copies of records.
• 21 CFR 11.10(c): Records protection and retrieval.
• 21 CFR 11.10(d): Limited system access.
• 21 CFR 11.10(e): Secure, computer-generated, and time-stamped audit trails.
• 21 CFR 11.10(f): Operational system checks.
• 21 CFR 11.10(g): Authority checks.
• 21 CFR 11.10(h): Device checks.
• 21 CFR 11.10(i): Appropriate personnel training and experience.
• 21 CFR 11.10(j): Implemented written policies.
• 21 CFR 11.10(k): Appropriate control of system documentation.

However, when the system is only utilized for generating printouts and has minor significance in record creation, companies may choose not to implement the requirements for electronic records mentioned above. In this case, companies must justify the system’s incidental use.

In cases where open systems are used, and validation is required, companies must implement requirements from 21 CFR Part 11.10 and 11.30.

These requirements specify additional security measures, such as document encryption and appropriate digital signature standards, to ensure data authenticity from the point of transmission to the receipt.

For further information about the difference between closed and open systems, read our article on this topic.

Conduct 21 CFR Part 11 Electronic Signatures Assessment

The 21 CFR Part 11 electronic signatures assessment evaluates if the system uses electronic signatures and must comply with the applicable regulatory requirements.

Companies should answer the following question about their systems:

• Does the system use electronic signatures to sign records as required by agency regulations or departmental SOPs?

Conclude on 21 CFR Part 11 Electronic Signatures Assessment

The conclusion of the 21 CFR Part 11 electronic signatures assessment is based on the answers obtained during the evaluation above.

If the system uses electronic signatures to sign records as required by agency regulations or departmental SOPs, it must comply with the minimum applicable 21 CFR Part 11 requirements for electronic signatures.

The requirements for electronic signatures as per 21 CFR Part 11 are:

• 21 CFR 11.50: Signature information included in the signed record.
• 21 CFR 11.70: Linked electronic signatures to their respective records.
• 21 CFR 11.100(a): Unique signature for each individual.
• 21 CFR 11.100(b): Verified users identity.
• 21 CFR 11.100(c): Handwritten signatures equivalent to electronic signatures.
• 21 CFR 11.200(a)(1): Two distinct identification components for non-biometric signatures.
• 21 CFR 11.200(a)(1)(i): Serial signing for non-biometric signatures. The first signing requires both signature components, and subsequent signings require one component.
• 21 CFR 11.200(a)(1)(ii): Non-Serial signing for non-biometric signatures. Require both components.
• 21 CFR 11.200(a)(2): Non-biometric signatures are used by their genuine owners.
• 21 CFR 11.200(a)(3): Required collaboration of individuals to prevent unauthorized use of non-biometric signatures.
• 21 CFR 11.200(b): Biometric signatures are used by their genuine owner.
• 21 CFR 11.300(a): Unique identification code and password combination.
• 21 CFR 11.300(b): Identification code and password are periodically checked.
• 21 CFR 11.300(c): Loss management procedures.
• 21 CFR 11.300(d): Transaction safeguards to prevent unauthorized use of passwords and identification codes.
• 21 CFR 11.300(e): Initial and periodic testing of devices.

If 21 CFR Part 11 is found to be necessary, you can use our 21 CFR Part 11 compliance checklist to evaluate the level of compliance with the requirements outlined in 21 CFR Part 11.

Role of 21 CFR Part 11 Compliant Software

21 CFR Part 11 compliant software solutions are specifically designed to meet the requirements outlined in 21 CFR Part 11, which governs electronic records and signatures.

By using 21 CFR Part 11 compliant software, Life Science companies can streamline their processes, improve data integrity, and effectively manage electronic records in a compliant manner.

They provide the necessary capabilities to help ensure the integrity, security, and authenticity of electronic records and signatures.

SimplerQMS provides an eQMS solution tailored to assist companies in streamlining their quality management processes and helping ensure compliance with the requirements of 21 CFR Part 11.

We offer a 21 CFR Part 11 compliant software solution and already went through the applicability assessment, so you can leave your worries about the applicability assessment behind.

SimplerQMS offers an eQMS software solution that goes beyond 21 CFR Part 11 compliance. Our platform supports compliance with various Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 210, 211, and 820, EU GMP Annex 11, EU GMP, and more. With our extensive QMS process support, SimplerQMS software solution helps companies meet the necessary standards and regulations.

We offer Life Science QMS modules such as document management, change control, employee training, CAPA management, customer complaints, supplier management, and more.

To gain a deeper understanding of the advantages of implementing an eQMS solution, we recommend downloading our eQMS Business Case template.

The template is a valuable resource that offers a structured methodology for assessing the value of an eQMS customized to suit your company’s unique needs, enabling you to communicate your findings to management effectively.

You can uncover potential cost savings, better operational efficiency, and improved compliance through a comprehensive business case analysis.

Final Thoughts

The 21 CFR Part 11 applicability assessment is a process used to determine whether a computerized system utilized for managing electronic records and electronic signatures falls within the scope of the 21 CFR Part 11 requirements.

SimplerQMS utilizes the Regulatory Criticality Assessment (RCA) as our 21 CFR Part 11 applicability assessment, which includes a decision pathway with essential questions for companies to address to identify necessary 21 CFR Part 11 controls.

Implementing 21 CFR Part 11 compliant software solutions is essential for Life Science companies looking to improve data integrity, streamline processes, and effectively manage electronic records and signatures.

If you would like to learn more about how SimplerQMS can improve your quality management and compliance efforts, schedule a demo today to talk with our quality experts.

The post 21 CFR Part 11 Applicability Assessment appeared first on SimplerQMS.

It is important to properly manage training records to demonstrate that employees have completed their training and showcase their ongoing training progress. 

In this article, we will discuss the significance of training records, mention the records falling under the purview of 21 CFR Part 11, outline the associated requirements, and highlight best practices. Additionally, we will explore how an eQMS can simplify training records management. 

Life Science companies are adopting Document Management and Quality Management System (QMS) software solutions that comply with 21 CFR Part 11 to streamline regulated quality management processes, such as training management, and ensure compliance.

SimplerQMS provides QMS software fully compliant with 21 CFR Part 11, designed for Life Science companies. To learn how our eQMS can help you streamline your quality process management and compliance efforts, you can book a demo of SimplerQMS and talk with our system experts. 

Learn about 21 CFR Part 11 and training records by exploring these topics: 

• Importance of Training Records
• Which Training Records Fall Under the Purview of 21 CFR Part 11?
• Requirements for Training Records Under 21 CFR Part 11
• Best Practices for Managing Training Records
• Simplify Training Records Management and Entire QMS with SimplerQMS

Importance of Training Records 

Training records play an important role as they provide documented evidence of the training activities conducted within an organization, ensuring that employees are adequately trained and qualified to perform their assigned tasks. 

Inadequate or poorly managed training records increase the risk of noncompliance during regulatory inspections and audits. These can lead to warning letters, product detention, monetary penalties, and company reputation damage. 

To avoid these consequences, Life Science companies should have well-maintained training records in compliance with 21 CFR Part 11 requirements, particularly when electronic records are utilized. 

The main benefits of well-maintained training records include the following: 

• Comprehensive training details: Training records track various aspects of training, including attendance, training effectiveness via quiz results, and more. 
• Risk mitigation: Well-maintained training records contribute to effective risk management. Organizations can implement targeted training interventions to address these deficiencies by identifying employee knowledge or skills gaps. 
• Audit preparedness: Well-maintained training records facilitate audits and inspections by demonstrating that employees are trained to perform their tasks according to regulatory requirements.
• Competency validation: Training records serve as a documented validation of employee competency. They provide proof that individuals have completed the required training, acquired the essential knowledge and skills, and are qualified to carry out their assigned tasks. 

Which Training Records Fall Under the Purview of 21 CFR Part 11? 

All training records created, maintained and stored electronically fall under the purview of 21 CFR Part 11. 

Some examples of training records that fall under the purview of 21 CFR Part 11 include: 

• Training attendance records: These records track which employees have attended training and the date and time of their attendance. The record would typically include the trainer’s name and the training topic. 
• Training logs or training registers: These records track the training that employees have received. They can include the date and time of the training, the topic of the training, the trainer’s name, and the employee’s attendance.  
• Training assessment results: Assessments, such as quizzes, can help measure an employee’s understanding of the training material. They can be used to identify areas where the employee needs additional training or to track the effectiveness of the training program.  
• Training certificates: Certificates demonstrate that employees completed training and have the necessary skills to perform their tasks. 
• Training evaluation forms: Evaluation forms are used to collect feedback from employees about the training they have received. The feedback can be used to improve the training program or to identify areas where additional training is needed. 

Training records should be retained for the required period. The time that training records must be retained varies depending on the specific industry and regulatory requirements. 

Requirements for Training Records Under 21 CFR Part 11 

The 21 CFR Part 11 requirements for training records follow the requirements outlined for electronic records. These requirements are designed to ensure training records’ authenticity, integrity, and confidentiality. 

This section will explore the requirement for training records under 21 CFR Part 11 and emphasize the most important areas. 

System Validation 

The system must be validated to ensure that the electronic system effectively creates, maintains, and stores accurate training records in compliance with 21 CFR 11.10(a). It also should include testing the system’s ability to detect and differentiate unauthorized or modified training records. 

Validation is necessary if the electronic system is used to manage processes regulated by ISO 13485, 21 CFR Part 820, EU GMP. These regulations emphasize the importance of using a validated computer system when controlling and documenting regulated processes, such as training management. 

Generate Copies of Training Records 

The system should generate copies of training records. These copies must be suitable for inspection, review, and copying by the FDA, according to 21 CFR 11.10(b). 

This ensures that organizations can provide authorized personnel from the FDA with readily accessible and accurate copies of training records when requested during inspections or audits. Having the ability to generate such copies facilitates compliance with regulatory obligations and streamlines the process of providing evidence of training activities to regulatory authorities. 

Retrieval of Training Records 

Training records should be stored in a way that allows them to be retrieved accurately and readily throughout the records retention period as per 21 CFR 11.10(c). 

This means that Life Science companies should have a process for retrieving training records in response to FDA or employee requests. 

Limit Access to Training Records 

Access to training records should be limited to authorized individuals to maintain confidentiality and prevent tampering in accordance with 21 CFR 11.10(d).  

Companies must implement a secure and dependable process to restrict access, assigning permissions based on license types and user roles. 

By implementing access controls, organizations can safeguard the integrity and confidentiality of training records, protecting them from unauthorized modifications or disclosures. 

Limiting access ensures that only individuals with a legitimate need to view or modify the records, such as HR personnel, trainers, and management, can access them. 

Audit Trails 

The system must generate secure and time-stamped audit trails of training records in compliance with 21 CFR 11.10(e).  

The audit trails should include precise information, such as the identity of the individual who made the changes, the time stamp indicating when the changes were made, and a clear record of the purpose or reason for each change. 

This level of detail ensures transparency and accountability, allowing organizations to track the history of changes made to training records and understand the context behind each modification. 

Provide Recordkeeping System Training  

Companies should provide training to individuals responsible for using electronic systems to handle training records in accordance with 21 CFR 11.10(i). 

This requirement helps ensure personnel have the education, training, and experience to perform their assigned tasks using the system. 

Written Policies for Training Records 

Companies should establish written policies that hold individuals accountable for training actions initiated under their name, in compliance with 21 CFR 11.10(j). 

These policies serve to prevent document falsification and maintain training records’ integrity. 

Organizations can set clear expectations and guidelines for proper handling and managing training records by implementing written policies. 

Electronic Signatures 

Signed training records must contain information associated with the electronic signature in compliance with 21 CFR 11.50. This information includes the signer’s name, date, time, and signature meaning. 

Additionally, the electronic signature data, conforming to 21 CFR Part 11 electronic signature requirements, must be included in the training record in both electronic display and printout forms. This ensures that the integrity and authenticity of the electronic signature are preserved, providing a reliable record of the individual’s endorsement of the training record. 

Linking Signatures to Training Records 

For training records to be protected from being falsified, signatures executed on them must be linked to the corresponding record in compliance with 21 CFR 11.70. 

By linking signatures to specific training records, organizations ensure that the signature is intrinsically tied to the content and context of the record. This linkage establishes a clear and unbroken chain of evidence, making it virtually impossible for signatures to be removed or transferred to another document without detection. 

In this article, we discussed the training record requirements specified in 21 CFR Part 11. However, in this part of the regulation are several other requirements. Check our dedicated article on 21 CFR Part 11 requirements if you want to learn more. 

Best Practices for Managing Training Records 

Implementing best practices for effectively managing training records under 21 CFR Part 11 helps Life Science companies achieve and maintain compliance when using electronic records. 

Some best practices for managing training records are listed below. 

Implement a Validated Electronic System 

Validation ensures that the electronic system operates accurately, reliably, and consistently according to its intended performance. By validating the system, companies can have confidence in the integrity of their electronic records. 

Moreover, validation is mandatory when using the electronic system to manage ISO 13485, 21 CFR Part 820, EU GMP regulated processes. 

Establish Written Policies and Procedures 

Companies should establish written policies and procedures to ensure accountability and prevent record falsification when managing training records. 

Clear and comprehensive guidelines are essential in this regard. 

These policies should clearly outline the responsibilities and expectations of individuals involved in training activities. 

Protect Training Records from Unauthorized Changes 

System access should be limited to relevant personnel, safeguarding the security and integrity of records. This practice ensures effective record management, prevents unauthorized changes, and protects sensitive information. 

Companies should implement user authentication mechanisms like secure login credentials and role-based access controls to restrict access. Regularly reviewing and updating access privileges helps protect records and achieve compliance with data security regulations. 

Track Training Records Using Time-Stamped Audit Trails 

Time-stamped audit trails allow companies to have a dependable and transparent system for recording training activities. 

With time-stamped audit trails, each action associated with training records is recorded along with the date, time, and responsible person. Activities include completing training, answering quizzes, accessing attempts, and so on. 

Sign Training Records With Electronic Signatures 

Electronic signatures offer a secure and convenient way to sign off training records. They should be unique to one individual and not be reused by, or reassigned to, anyone else.  

Electronic signatures should employ at least two distinct identification components – an identification code and a password. This helps ensure the authenticity and integrity of training records by using genuine signatures. 

Establish Robust Data Backup and Recovery Process 

Effectively maintaining training records involves establishing a robust data backup and recovery process. 

Companies should safeguard training records and swiftly recover them in case of unforeseen events or system failures. One way is implementing regular backup schedules, utilizing redundant storage, securing backup data, performing verification tests, and documenting the recovery process. 

Simplify Training Records Management and Entire QMS with SimplerQMS 

SimplerQMS is a comprehensive QMS software that helps Life Science companies achieve and maintain 21 CFR Part 11 compliance.  

Our software is designed to streamline quality management processes, including training management. 

The Training Management Software module from SimplerQMS provides companies with easy control management over their employee training records. 

The Training Management module allows training managers to define specific documents for learning and assign them to individuals or job roles. They can also set a timeframe for learning the training material, create quizzes to assess the effectiveness of the training, and use electronic signatures to streamline the process. 

The module also enables training managers to create training plans that outline employee training schedules. The system sends reminders and notifications about upcoming training activities and due dates. 

In addition to the robust Training Management module, we offer all Life Science QMS modules, which include document management, change control, audit management, CAPA, customer complaints, supplier management, and more. 

SimplerQMS supports compliance with several Life Science requirements, such as FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q10, MDR and IVDR, FDA 21 CFR Part 210, 211, and 820, ISO 13485:2016, ISO 15189:2022, and more. 

Our eQMS Business Case template can help you identify the value of an eQMS solution and communicate it to stakeholders. It serves as a guide for assessing your organization’s needs, identifying the benefits of an eQMS, and developing a business case for implementation while ensuring that all relevant factors are considered. 

Final Thoughts 

The FDA outlines electronic records and signature requirements in the 21 CFR Part 11. The regulation sets forth requirements for creating, maintaining, and using electronic records, that includes training records. 

Training records provide evidence of employee training. They demonstrate an employee’s progress in training, indicating, for instance, training completion. 

Companies across various Life Science industries are adopting 21 CFR Part 11-compliant electronic systems to securely manage documentation, including training records. 

SimplerQMS offers eQMS software to help Life Science companies streamline quality management processes, including training management, and achieve compliance. 

If you are interested in learning more about 21 CFR Part 11 compliant QMS software and how SimplerQMS can help you meet your compliance needs, book a demo today. 

The post 21 CFR Part 11 and Training Records (What You Should Know) appeared first on SimplerQMS.

The regulation aims to ensure the authenticity, integrity, and, when appropriate, confidentiality of electronic records used in FDA-regulated industries.

Life Science industries, such as pharmaceuticals, biotechnology, CRO, and medical devices, are required to maintain accurate and secure electronic records when operating in the US market.

The article discusses the definition of electronic records, requirements as per 21 CFR Part 11, and key recordkeeping system features. Moreover, it examines how an electronic QMS solution, like SimplerQMS, supports compliance with 21 CFR Part 11.

Life science companies have been increasingly adopting Document Management and electronic QMS solutions that are 21 CFR Part 11 compliant to simplify achieving and maintaining compliance.

The following topics will help you understand 21 CFR Part 11 compliant electronic records:

• Electronic Record Definition as per 21 CFR Part 11
• What are 21 CFR Part 11 Electronic Records Requirements?
• Key Electronic Recordkeeping System Features
• How SimplerQMS Meets 21 CFR Part 11 Electronic Records Requirements

Electronic Record Definition as per 21 CFR Part 11

Electronic records are defined as any combination of text, data, audio, or other information in a digital form managed within computer systems, according to 21 CFR 11.3(b)(6).

This means that text documents are not the only information assets included here, but also the following:

• Images
• Sound files
• Graphics
• Videos
• Test records
• Source code
• Spreadsheets
• And more

Companies subject to 21 CFR Part 11 must develop and implement procedures and controls for creating, maintaining, and transmitting electronic records. Employing such procedures and controls in compliance with the regulation helps ensure that records are genuine, confidential, and free from tampering.

In the Life Sciences, 21 CFR Part 11 can be applied to electronic records related to the safety, efficacy, and quality of human and veterinary drugs, medical devices, and biological products.

Here are three examples of electronic records used in Life Science companies:

• Electronic laboratory notebooks: Electronic notebooks are used to record the results of experiments and other scientific data. They are an important part of the scientific record and should be maintained in a secure and accessible manner.
• Manufacturing records: Manufacturing records are used to track the production of drugs, medical devices, and other products. They should be maintained in a way that allows for the traceability of materials throughout the entire product life cycle.
• Training records: Training records are used to document the training of employees. They should be able to provide evidence of employees’ skills and competency.

What are 21 CFR Part 11 Electronic Records Requirements?

The 21 CFR Part 11 outlines the electronic records requirements for procedures and controls Life Science companies must employ to ensure the authenticity and integrity of records.

All the requirements for electronic records are specified in the 21 CFR Part 11 Subpart B.

The following sections will briefly explain the electronic record requirements according to 21 CFR Part 11.

Controls for Closed Systems (Section 11.10)

A closed system means a secure environment where only authorized users can access electronic records.

Companies that use closed systems to handle electronic records should have procedures and controls to ensure that the records are authentic, complete, and secure as per 21 CFR 11.10.

These procedures and controls should also help to prevent people from denying that they are the genuine signers of a record.

Procedures and controls for electronic records must include the following:

• System validation: Ensure system performance is accurate and reliable and can detect invalid or altered records.
• Record generation: Generate accurate and complete copies of records in human-readable and electronic form.
• Record protection: Protect records so they can be retrieved accurately and easily throughout the retention period.
• System access: Limit system access to authorized individuals.
• Audit trails: Maintain secure, computer-generated, and time-stamped audit trails of operator entries and actions.
• System checks: Enforce a specific permitted sequence of steps and events in the workflow.
• Authority checks: Ensure only authorized individuals can use the system, sign records, access data, or alter records.
• Device checks: Validate the source of data input and operational instructions.
• Employee training: Ensure personnel have the necessary education, training, and experience to perform their assigned tasks.
• Quality policies: Establish written policies that hold individuals accountable for actions in records initiated under their name.
• System documentation: Implement appropriate controls over systems documentation, including distribution, access, and use.
• Revision and change control: Maintain an audit trail of the time-sequenced development and modification of systems documentation.

Controls for Open Systems (Section 11.30)

An open system means an environment where anyone can access electronic records.

Companies using open systems must implement the same requirements applicable to closed systems.

However, there is the need to use an extra layer of security with measures such as document encryption and appropriate digital signature standards as per 21 CFR 11.30.

If you want to learn more about the difference between open and closed systems, our article is a great place to start.

Signature Manifestations (Section 11.50)

In accordance with 21 CFR 11.50, electronic records that are signed must include the following information:

• The printed name of the signer
• The date and time of signature
• The meaning associated with the signature

This information regarding the electronic signature must be under the same controls as the electronic record and must be included in the document.

Signature and Record Linking (Section 11.70)

Electronic and traditional handwritten signatures must be linked to the electronic records they are signed on as per 21 CFR 11.70.

This measure prevents the signatures from being removed, copied, or transferred to falsify the records.

While this article focuses on the electronic records requirements specified in 21 CFR Part 11, it is important to note that several other requirements are outlined in this part of the regulation. Please refer to our article on 21 CFR Part 11 requirements to understand other requirements in this regulation.

Key Electronic Recordkeeping System Features

Utilizing key features and functionalities of an electronic recordkeeping system helps Life Science companies ensure that their electronic records comply with 21 CFR Part 11.

Here, we mention some key features of an electronic system regarding electronic records. Keep in mind that this is not an exhaustive list. Overall, the 21 CFR Part 11 compliant system should be able to ensure the authenticity, confidentiality, and integrity of electronic records.

The key features of an electronic recordkeeping system to comply with 21 CFR Part 11 include:

Record Generation

The ability to generate accurate and complete copies of records is essential for compliance with 21 CFR 11.10(b).

The system must be able to generate copies of records in both human-readable and electronic form. The written form should be easy to read and understand. And the electronic form should be suitable for inspection, review, and copying by the FDA.

Data Retrieval

The system must ensure that electronic records can be easily accessed and retrieved during their retention period as per 21 CFR 11.10(c).

This means that the system must have a robust search and retrieval capability. Users should be able to find the records they need using keywords easily. They should also be able to view and print the records in a timely manner.

Access Controls

The system should have robust access controls that prevent unauthorized users from accessing electronic records in compliance with 21 CFR 11.10(d).

Access controls should be based on the license type and user role, meaning users should only be given access to the records they need to perform their assigned tasks.

Passwords are an important type of access control, as they can restrict access to the system. Strong and unique passwords that are changed regularly can help to protect electronic records from unauthorized access. Read our complete article to learn more about password requirements as per 21 CFR part 11.

Comprehensive Audit Trails

The system should maintain comprehensive audit trails that track all actions related to electronic records as outlined in 21 CFR 11.10(e).

This includes who accessed the records, when, and what they did.

Audit trails can also be used during audits to show a complete sequence of events in the workflow, demonstrating if the processes are being followed accordingly.

Audit trails are useful for investigating unauthorized access, data manipulation, or other issues within the system.

Control of System Documentation

The system should offer controls to ensure documentation is accurate, complete, and up-to-date as mentioned in 21 CFR 11.10(k). This includes the quality manual, policies, procedures, work instructions, training materials, and so on.

Documentation should be stored in a secure location and accessible to authorized users only.

Signature Data

The system should associate signature information with signed electronic records as per 21 CFR 11.50.

The signature data includes the signer’s name, date, time, and purpose associated with this signature. This information should be included in the electronic record in both electronic display and printout versions.

How SimplerQMS Meets 21 CFR Part 11 Electronic Records Requirements

SimplerQMS can help Life Science companies achieve 21 CFR Part 11 compliance by providing a comprehensive eQMS solution for managing electronic records and quality documentation.

SimplerQMS provides features and functionalities specifically designed to comply with Life Science requirements, including 21 CFR Part 11.

Here are some of the key capabilities that help companies achieve 21 CFR Part 11 compliance regarding electronic records:

Validated System

As per 21 CFR 11.10(a), the system must be in a validated state to ensure that it is accurate, reliable, performs as intended, and can identify invalid or altered records.

SimplerQMS is a fully validated system according to ISPE GAMP5. We automatically revalidate the system when a new version is created, or standard updates are applied.

SimplerQMS execute all QMS software validation processes, so customers do not need to spend extra resources or time on software validation.

Time-Stamped Audit Trail

SimplerQMS provides a comprehensive audit trail of all activity in the system.

This audit trail includes information such as who accessed a record, when, and what they did with it. The audit trail is computer generated and always accurate and up-to-date.

For instance, it automatically tracks relevant data when records are edited, reviewed, approved, or retired. This automatically creates a document history and enables a way to compare changes and roll back to previous versions if needed.

Document Management

SimplerQMS offers a 21 CFR Part 11 compliant document management system. It is easy to create, review, approve, and store electronic records in compliance with the requirements.

Our software also provides automated workflow, version control, document change management, and more. This helps to ensure that documents are accurate, complete, and up-to-date.

Employee Training

Receive personalized training from SimplerQMS to learn how to use our quality management system. We offer unlimited training sessions and support for all QMS modules.

The training is conducted in a dedicated environment to improve users’ confidence before using the software.

Moreover, companies can create their own training to facilitate onboarding new employees. We offer a complete training management module with features to simplify training assignments, automate reminders and notifications, create quizzes, and more.

Electronic Signatures

You can efficiently sign electronic records with SimplerQMS 21 CFR Part 11 compliant electronic signatures.

Signatures are automatically linked to their respective electronic records to prevent falsification. This helps to ensure the authenticity and integrity of electronic records.

Watch the video below to learn how SimplerQMS simplifies document signing with 21 CFR Part 11 compliant electronic signatures and automated workflows, notifications, and reminders.

Secure Data Storage and Retrieval

SimplerQMS uses cloud storage to keep records secure and always available anywhere.

A search feature allows users to retrieve records using keywords in the title and content. This helps to ensure that records can be easily found and accessed when needed, for example, during audits.

Limited System Access

Our software connects with Microsoft Entra ID (previously known as Microsoft Azure Active Directory) to manage system access, ensuring secure authentication and authorization.

Only verified and authorized personnel can access the system and specific records. Users have unique identification codes and passwords to access the system. This helps to protect the confidentiality of electronic records.

SimplerQMS provides much more than a 21 CFR Part 11 compliant electronic recordkeeping system.

We provide comprehensive eQMS software that helps Life Science companies to comply with several requirements. This includes FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q10, MDR and IVDR, FDA 21 CFR Part 210, 211, and 820, ISO 13485:2016, ISO 15189:2022, and more.

Our software offers broad QMS process support, and all Life Sciences QMS modules are integrated and work together seamlessly. This entails document management, employee training, change control, CAPA management, complaint management, audit management, supplier management, and others.

Getting started with your eQMS implementation could be as simple as downloading our eQMS Business Case template.

You can use this resource to evaluate the value of an eQMS for your company and present your findings to your management.

This template can help you ensure that all relevant factors have been considered and that you are making a compelling case for implementing an eQMS in your company.

Final Thoughts

The 21 CFR Part 11 outlines the electronic records requirements. Companies in FDA-regulated industries that use electronic records and signatures must comply with this part of the regulation to ensure electronic records’ authenticity, integrity, and confidentiality.

Several Life Science companies have been implementing 21 CFR Part 11 compliant software solutions to help achieve regulatory compliance, secure data integrity, and streamline processes while reducing costs.

SimplerQMS provides 21 CFR Part 11 compliant eQMS solutions tailored for Life Science companies. By streamlining quality management processes and eliminating manual paper-based documentation processes, we help improve efficiency and save costs.

We invite you to book a free demo and talk to SimplerQMS system experts. This will enable you to learn more about 21 CFR Part 11 compliant eQMS and how SimplerQMS can help you streamline quality management processes and achieve compliance faster.

The post 21 CFR Part 11 Compliant Electronic Records (Guide) appeared first on SimplerQMS.

It provides a comprehensive list of questions to consider when assessing the compliance of electronic records and electronic signature systems.

We offer a downloadable compliance checklist in PDF and Excel formats that contains questions as per 21 CFR Part 11 requirements organized into 7 categories:

• Validation
• Audit trail
• System
• Copies of records
• Record retention
• Electronic signatures
• Access security

Many Life Science companies are implementing 21 CFR Part 11 compliant Document Management Systems or eQMS solutions to make compliance easier. Throughout the article, we will give examples of how such solutions help ensure compliance.

SimplerQMS offers 21 CFR Part 11 compliant eQMS solutions tailored to the needs of Life Science companies. Book a personalized demo and talk to our experts to see how SimplerQMS can help you stay compliant and work more efficiently.

Downloadable 21 CFR Part 11 Compliance Checklists to Follow

A checklist helps with compliance assessment by making sure requirements are met.

First, it is important to understand whether your current system has any gaps between real-world situations and the requirements outlined in the FDA 21 CFR Part 11 (section-by-section).

The gap analysis can help identify the areas that need improvement to ensure compliance.

Here is the 21 CFR Part 11 checklist you can use for Gap Analysis purposes – you can download it in either PDF or Excel format.

Download the checklist for Gap Analysis in PDF format.

Download the checklist for Gap Analysis in Excel (XLS) format.

To assess the implementation of the FDA 21 CFR Part 11, you can use a compliance checklist.

Our downloadable 21 CFR Part 11 compliance checklist is available in PDF and Excel formats.

You can download the checklist by clicking the link below (depending on the preferred format).

Download the 21 CFR Part 11 compliance checklist in PDF format.

Download the 21 CFR Part 11 compliance checklist in Excel (XLS) format.

Below, we will go through the questions included in the checklist to help better understand each category and its purpose. We will also give examples of how modern eQMS solutions like SimplerQMS can help ensure compliance with some of these requirements.

Validation

The validation of computerized systems is an essential part of complying with 21 CFR Part 11, as stated in section 21 CFR 11.10(a).

Validation should be based on a justified and documented risk assessment, determining the system’s potential impact on record integrity. This could be done using a 21 CFR Part 11 Applicability Assessment to define whether a system performs functions regulated by 21 CFR Part 11.

Here are the questions related to system validation you would want to ask:

• Is the system validated?
• Is the system performance accurate, reliable, and consistent?
• Is the system able to identify invalid or altered records?
• Are there written policies in place that outline the accountability and responsibility of users for actions initiated under their electronic signatures?
• Are users informed and trained on the policies related to electronic signatures to prevent record and signature falsification?
• Can you provide training documentation demonstrating that individuals who develop, maintain, or use electronic record and signature systems have the required experience for their assigned tasks?
• Is there a documented process for verifying the identity of users before their electronic signature is established, assigned, or certified?
• Is the system designed to require the collaboration of two or more individuals to use an electronic signature that does not belong to them?

SimplerQMS offers a fully validated system following ISPE GAMP5 – a risk-based approach to compliant systems, to ensure that it is fit for its intended use.

Our software undergoes revalidation processes whenever a new version is released or when standard updates are applied.

This eliminates the need for our customers to conduct any system validation activities regarding SimplerQMS.

Audit Trails

Section 21 CFR 11.10(e) and 11.10(k)(2) specify the requirements for the generation and maintenance of accurate and complete audit trails that record all actions related to electronic records.

Companies should ensure the audit trail’s completeness, protect it from unauthorized access or modifications, and ensure it can be retrieved and reviewed as needed.

For more detailed information on the audit trail as per FDA 21 CFR Part 11, read our article on audit trail requirements.

Check off the following steps to ensure audit trail compliance:

• Are document management and change control procedures in place to maintain an audit trail?
• Does the system have a secure and computer-generated audit trail to record operator entries and actions that create, modify, or delete electronic records?
• Does the system record the date and time of these operator entries and actions on the audit trail?
• Do changes to records modify previously recorded information? Note that all previous information should still be accessible and not erased or hidden by changes.
• Is the audit trail documentation retrievable and available for FDA review and copying?

SimplerQMS solution automatically records all audit trail data entries in compliance with 21 CFR Part 11. The system creates an independent record of the date, time, username, and actions performed on electronic records.

All documents and related audit trails are stored in a cloud-based system for as long as required. Inspectors can easily view documents in the SimplerQMS system during audits.

Systems

The compliance requirements for electronic recordkeeping systems are outlined in Sections 21 CFR 11.10 and 11.30.

The system must be supported by documented evidence and justification that it is suitable for its intended use, which includes:

• Using electronic records and signatures
• Implementing access controls
• Performing system checks
• Managing distribution of system documentation.

You will need to check off the following steps:

• Does the company use electronic records?
• Does the company use electronic signatures?
• Does the company use handwritten signatures executed to electronic records?
• Does the company use electronic signatures based on biometrics?
• Does the system prevent electronic signatures based on biometrics from being used by anyone other than their genuine owners?
• Is the system designed to ensure that only authorized individuals can access it and perform actions?
• Does the system have controls to prevent unauthorized access to the operation or computer system input/output devices?
• Does an open system comply with the appropriate procedures and controls identified in section 11.10?
• Does an open system employ additional controls, such as document encryption and digital signature standards, to ensure record authenticity, integrity, and confidentiality?
• Is there a procedure to conduct device checks to ensure the data input source or operational instruction is valid?
• Does the system use operational checks to enforce actions to be executed in a predetermined sequence, if applicable?
• Are there controls in place for the distribution of system documentation?
• Is an access control procedure in place to ensure only authorized users can access system operation and maintenance documentation?
• Is there a procedure to ensure the proper use of system documentation for operation and maintenance?

Companies using the SimplerQMS solution, for instance, benefit from its closed-system architecture and security controls. This helps ensure that only authorized individuals can access and modify electronic records.

SimplerQMS connects with Microsoft Entra ID (previously known as Microsoft Azure Active Directory) for secure identity and access management. Each person has only one user account for a clear one-to-one relationship between the authorized person and their login account.

Copies of Records

Generating copies of records is an essential part of complying with 21 CFR Part 11, as stated in section 21 CFR 11.10(b).

FDA recommends that copies of records should accurately reflect the content and meaning of the original record. During an audit, you should allow reasonable and helpful access for the investigator to electronic records.

Go through the following questions to ensure your system can provide the required record copies for compliance:

• Is the system capable of producing accurate and complete copies of electronic records?
• Are electronic signatures linked to their respective electronic records preventing the removal, copying, or transfer of signatures?
• Can all electronic records be provided to the FDA for inspection and review?
• Are records in the system protected from unauthorized changes by having authorization checks in place?

SimplerQMS is a 21 CFR Part 11 compliant software that automatically links electronic signatures to records preventing them from being falsified.

Additionally, the software offers a controlled printing feature, which allows users to print or download copies of records while easily keeping track of all printouts.

Record Retention

Section 21 CFR Part 11.10(c) addresses record retention requirements for electronic records under FDA regulations.

Electronic records must be retained to ensure the records are accurate, complete, and secure during the entire retention period.

Check off the following elements to ensure the proper retention of your records:

• Do the signed electronic records contain information that indicates the signer’s printed name?
• Do the signed electronic records contain information indicating the date and time when the signature was executed?
• Do the signed electronic records contain information that indicates the meaning associated with the signature, such as review, approval, responsibility, or authorship?
• Is the level of control for signature information equivalent to that of electronic records?
• Are electronic records readily retrievable throughout their retention period?
• Is the audit trail documentation retained for the required period?

For instance, 21 CFR Part 11-compliant software solution, like SimplerQMS, ensures that all essential signature information is automatically captured and included in the electronic record.

The system has strict controls in place to manage both signatures and records, ensuring that all necessary information is displayed on the document.

SimplerQMS also offers a search feature to facilitate document retrieval.

It is possible to search keywords in titles and content of records to locate the precise document during daily activities or audit situations.

Electronic Signatures

Requirements for electronic signature use and controls are outlined in sections 11.100 and 11.200 of 21 CFR Part 11. Which also includes validation and authentication to ensure the signer’s identity.

This checklist section provides a structured and comprehensive approach to electronic signature validation and ensures that all critical aspects of the system are evaluated.

For more detailed information on electronic signatures, please read our 21 CFR Part 11 compliant electronic signatures article.

To ensure compliance with electronic signature requirements, verify the following steps:

• Are electronic signatures in the system restricted to authorized users only?
• Does each user have their own unique electronic signature?
• Are electronic signatures only being used by their genuine owners?
• Do electronic signatures use at least two different identification components, such as an identification code and password?
• Does the system require all electronic signature components for the first signature within a series of signatures in a single system access?
• Does the system require at least one electronic signature component for subsequent signatures?
• Does the system require all electronic signature components when a user signs during several system accesses?
• Is there a procedure to prevent signatures from being reassigned or reused?
• Did users provide a traditional handwritten signature on the Electronic Signature Agreement to acknowledge that their electronic signature is equivalent to a handwritten signature?
• Has the company ensured that everyone using electronic signatures in their system, used on or after August 20, 1997, has their certification submitted to the FDA?
• Has the company followed the submission guidelines on the FDA’s web page on the Letters of Non-Repudiation Agreement to certify electronic signatures?
• Are the users aware FDA may require them to provide additional certification or testimony of the equivalence of an electronic signature to their handwritten signature?

SimplerQMS requires at least two different identification components, such as an identification code and password, for electronic signatures. This ensures that only genuine owners can use their signatures.

The system also follows procedures to prevent electronic signatures from being reassigned or reused by someone else, ensuring that signatures are unique and cannot be used by anyone else.

Access Security

Proper identification code and password controls are essential to maintain access security per section 21 CFR Part 11.300.

One way to ensure compliance with these controls is to implement best practices for password creation and management, which you can learn more about in our article on 21 CFR Part 11 password requirements.

Additionally, specific procedures and checks ensure unique, valid, and secure identification codes and passwords. It is also important to manage lost or compromised credentials and devices.

Ensure access security by checking off the following:

• Are controls in place to ensure each individual has a unique identification code and password combination?
• Is the system capable of preventing the creation of duplicate identification code and password combinations?
• Are passwords required to expire and be updated periodically?
• Are there any procedures in place to recall or revise identification codes and passwords if necessary?
• Is there a procedure to periodically check the validity of the identification code and password combinations recorded in the system?
• Are there procedures to revoke identification code and password combinations that may have been compromised?
• Is there a procedure for recalling identification codes and passwords if someone leaves the company?
• Is there a procedure to disable lost, stolen, or missing electronic devices to protect system access and sensitive data?
• Are temporary or permanent password replacements issued using appropriate and rigorous controls?
• Does the system detect attempts of unauthorized use of passwords and identification codes?
• Is the system security unit immediately informed of any unauthorized use attempts of passwords and identification codes?
• Is organizational management notified of any unauthorized use of passwords and identification codes, if appropriate?
• Does the company perform initial testing on devices that generate or hold identification codes or password information to ensure they function properly?
• Does the company perform periodic device testing to ensure they still function properly?
• Is there a procedure to test for unauthorized device alterations that generate or hold identification codes or password information?

For example, SimplerQMS employs Microsoft Entra ID (previously known as Microsoft Azure Active Directory) for managing access control and electronic signature components.

Each signing credential has a unique signature assigned to it, along with a specific user identification code and password.

Our software enforces strict password security by requiring passwords to have a minimum length of eight characters, including at least one uppercase letter, one lowercase letter, and one digit.

Furthermore, passwords in SimplerQMS expire and are required to be updated every three months.

Here Are the Checklists In Case You Did Not Get Them Yet

Checklist for the purpose of Gap Analysis:

• Download in PDF format (printable)
• Download in Excel format

21 CFR Part 11 compliance checklist for assessing the implementation:

• Download in PDF format (printable)
• Download in Excel format

Going Beyond 21 CFR Part 11 Compliance With SimplerQMS

SimplerQMS not only meets but exceeds the 21 CFR Part 11 compliance requirements.

We offer a complete QMS software solution designed specifically for the Life Science industries and fully compliant with 21 CFR Part 11.

Here are some of the key SimplerQMS features that help ensure compliance with 21 CFR Part 11:

• Document Management: Our software enables easy creation, storage, organization, and retrieval of electronic records. SimplerQMS provides 21 CFR Part 11 compliant document management capabilities that include version control, automated numbering, change control management, and more.
• Electronic Signatures: With SimplerQMS is possible to work with electronic signatures easily, providing security and eliminating the need for physical signatures. Our software links electronic signatures to electronic records, ensuring document authenticity, integrity, and confidentiality.
• User Access Control: SimplerQMS uses Microsoft Entra ID to manage system access. The software also allows companies to assign roles and responsibilities to employees and control who can access the system by setting access levels based on user groups.
• Time-stamped Audit Trails: SimplerQMS keeps track of every change in records and provides an audit trail that includes the date and time of each change. This helps to identify who performed what, when, and the reason why.
• Training and Support: We offer training to ensure users are familiar with the system and can use electronic records and signatures for assigned tasks. The integrated training module allows for easy employee training management and tracking, including 21 CFR Part 11 process-specific training.

SimplerQMS is a complete eQMS solution for Life Science companies.

We provide integrated QMS modules such as document management, employee training, change control, non-conformance, customer complaint, CAPA, supplier management, and more.

The software streamlines processes and ensures compliance with regulations, such as 21 CFR Part 11, and many other Life Science regulations and standards, while saving time and resources.

Allowing companies to focus on more value-adding activities, such as product research and development. In other words, allocating more time and resources toward innovation, improving products and services, and staying ahead of the competition.

To evaluate the benefits of eQMS, we suggest downloading our eQMS Business Case template. It helps you identify potential ROI (Return on Investment) and present findings to management.

Final Thoughts

Use our free 21 CFR Part 11 checklists for Gap Analysis and compliance assessment to identify areas for improvement, and reduce the risk of non-compliance.

Furthermore, Life Science companies must go beyond just 21 CFR Part 11 compliance and embrace modern digital solutions to manage quality processes more effectively. Implementing QMS software helps streamline processes and move towards a culture of continuous improvement.

SimplerQMS provides a comprehensive solution, including all QMS modules such as document control, change control, training, non-conformance, CAPA, supplier, audit management, and more. The system also fully complies with 21 CFR Part 11 requirements for electronic records and signatures.

If you are interested in learning more about SimplerQMS and how we can help your company ensure 21 CFR Part 11 compliance and streamline quality management processes, book a free demo today.

The post 21 CFR Part 11 Compliance Checklist [PDF & XLS Download] appeared first on SimplerQMS.

This part of the regulation governs how electronic records and signatures are managed and utilized to ensure data integrity in Life Science industries, such as pharmaceuticals, medical devices, biotechnological, and other FDA-regulated industries.

One way for Life Science companies to comply with 21 CFR Part 11 is to adopt a compliant Document Management System (DMS) or electronic Quality Management System (eQMS), such as SimplerQMS.

In this article, we will discuss the different parts and requirements of the 21 CFR Part 11, as well as the key benefits of compliant systems. Furthermore, we will explain how SimplerQMS complies with these requirements.

SimplerQMS offers 21 CFR Part 11 compliant QMS software designed for Life Science companies. Book a demo today to see how our eQMS can help streamline your company’s quality management and compliance efforts.

Jump to the specific topics covered in this article:

• Introduction to 21 CFR Part 11 Requirements
• Different Parts of 21 CFR Part 11
• What Are the Requirements of 21 CFR Part 11?
• Key Requirements of a 21 CFR Part 11 Compliant System
• What Are the Key Benefits of Using a 21 CFR Part 11 Compliant System?
• How Does SimplerQMS Comply With 21 CFR Part 11 Requirements?

Introduction to 21 CFR Part 11 Requirements

The FDA 21 CFR Part 11 requirements apply to companies operating in FDA-regulated industries using electronic records and electronic signatures (eSignatures). In the Life Sciences, those include pharmaceutical, biotechnological, medical device, and other industries.

The purpose of these requirements is to ensure that electronic records and electronic signatures are just as trustworthy and reliable as paper records and handwritten signatures. These requirements are designed to ensure data integrity, security, and reliability in electronic records and signatures.

Electronic records are defined in 21 CFR 11.3(b)(6) as any information in digital form handled by a computer system.

This means that not only text documents are in scope but also the following information assets:

• Images
• Sound files
• Videos
• Test records
• Source code
• Spreadsheets

The FDA defines electronic signatures as any symbols an individual has approved as the legal equivalent of their handwritten signature as per 21 CFR 11.3(b)(7).

Compliance with 21 CFR Part 11 is essential for companies within FDA-regulated industries. Since nonconformances can result in serious consequences, including warnings, monetary penalties, product recalls, etc.

By ensuring compliance with 21 CFR Part 11, companies can maintain the authenticity, integrity, and, when appropriate, the confidentiality of their data.

Different Parts of 21 CFR Part 11

The FDA 21 CFR Part 11 is divided into three subparts, each addressing a different aspect of electronic records and signatures.

Below is a brief explanation of each subpart.

• Subpart A – General Provisions: This subpart outlines the scope and applicability of 21 CFR Part 11, as well as the definitions of key terms used throughout the regulations.
• Subpart B – Electronic Records: This subpart establishes requirements for the creation, modification, and maintenance of electronic records, including guidelines for data security, audit trails, and electronic signatures.
• Subpart C – Electronic Signatures: This subpart guides the use of electronic signatures, including the requirements for their use and how to control identification codes and passwords.

What Are the Requirements of 21 CFR Part 11?

The 21 CFR Part 11 requirements outline criteria for electronic records, electronic signatures, and handwritten signatures on electronic records to be considered trustworthy, reliable, and comparable to paper records and signatures on paper.

In this section, we will examine the key requirement of 21 CFR Part 11 and highlight the most important points.

21 CFR Part 11 Subpart A – General Provisions

Subpart A provides an overview of the requirements that companies using electronic records and signatures must meet to comply with these regulations.

Section 11.1 Scope

Section 11.1 Scope states that the FDA considers electronic records and signatures trustworthy, reliable, and equivalent to paper records and handwritten signatures.

This regulation applies to electronic records created, handled, and archived under any records requirements set forth by FDA. And records that meet the requirements of this part can be used instead of paper records unless paper records are specifically required.

Computer systems, controls, and documentation maintained under 21 CFR Part 11 must be available for FDA inspection.

Section 11.2 Implementation

Companies can use electronic records and electronic signatures as a substitute for paper records or handwritten signatures if they comply with Part 11 requirements.

Section 11.3 Definition

The FDA defines specific terms used in Part 11 for better understanding.

• Act: Federal Food, Drug, and Cosmetic Act.
• Agency: Food and Drug Administration (FDA).
• Biometrics: Method of verifying an individual’s identity based on unique physical features or repetitive action.
• Closed system: Environment where responsible persons for the electronic records control access to the system.
• Digital signature: Electronic signature based on cryptography, using computer science rules and parameters to convert signature information into a code.
• Electronic record: Any digital form of information representation created, modified, maintained, archived, retrieved, or distributed by a computer system.
• Electronic signature: Computer data of symbols authorized by an individual to be the legally binding equivalent of a handwritten signature.
• Handwritten signature: Scripted name or legal mark of an individual used to authenticate records.
• Open system: Environment where responsible persons for the electronic records do not control system access.

21 CFR Part 11 Subpart B – Electronic Records

Subpart B outlines the specific controls required for closed and open systems, as well as the necessary signature manifestations and linking.

Section 11.10 Controls for Closed Systems

Companies using closed systems must have controls and procedures to ensure electronic records’ authenticity, integrity, and, when appropriate, confidentiality.

These procedures and controls must include the following:

• Validate systems to ensure accuracy, reliability, and consistent performance.
• Produce complete and accurate copies of records for review and copying by the FDA.
• Retrieve records accurately and easily throughout the retention period.
• Limit system access to authorized personnel.
• Secure, computer-generated, and time-stamped audit trails.
• Operational system checks to enforce the correct sequence of steps and events.
• Authority checks to ensure only authorized individuals have access to the system, can electronically sign records, alter records, or perform the operation at hand.
• Device checks to verify the source of data input or operational instruction.
• Train the personnel who use electronic records and signature systems.
• Written policies that hold individuals accountable and responsible for actions under their electronic signatures.
• Controls over systems documentation, including adequate distribution, access, and use of system operation and maintenance documents.

Section 11.30 Controls for Open Systems

The same requirements for closed systems apply to open electronic systems, with additional security measures, such as digital signature standards and data encryption.

Section 11.50 Signature Manifestations

Electronic signatures must include an individual’s name, date, time, and meaning of the signature.

Section 11.70 Signature and Record Linking

An electronic signature must be associated with its respective electronic record. This ensures that the signature cannot be separated from the record to be falsified.

21 CFR Part 11 Subpart C – Electronic Signatures

Subpart C specifies the requirements for electronic signature components and controls, as well as controls for identification codes and passwords.

Section 11.100 General Requirements

This section sets forth the requirements to ensure the identity of users and certify their signatures.

General requirements include:

• Unique electronic signatures to each individual that cannot be reused or reassigned.
• Companies must verify the identity of individuals before assigning electronic signatures.
• Users of electronic signatures must certify to the FDA that their electronic signatures are the legal equivalent of traditional handwritten signatures.

Section 11.200 Electronic Signature Components and Controls

There should be at least two identification components, such as an identification code and password.

Electronic signatures must only be used by their genuine owners and administered, so the system should require an identification code and password when a user signs a record for the first time.

Users can use only one signature control component for subsequent signings during single system access. However, all electronic signature components should be used for each signing that is not performed during single system access.

Section 11.300 Controls for Identification Codes and Passwords

Companies using electronic signatures with identification codes and passwords must have controls to ensure security and integrity.

These controls include ways to:

• Ensure each user has a unique identification code and password combination without duplication.
• Periodically review and update identification code and password issuances, preventing password aging.
• Deactivate and replace lost, stolen, or potentially compromised devices containing identification codes or password information.
• Prevent unauthorized use of passwords and identification codes with transaction safeguards.
• Detect and report any unauthorized use attempts to the security unit and, if necessary, to management.
• Test devices periodically to ensure they work correctly and have not been altered.

Key Requirements of a 21 CFR Part 11 Compliant System

In this section, we will discuss the key requirements that a 21 CFR Part 11 compliant system must meet to achieve compliance.

While this article covers some of the 21 CFR Part 11 software requirements, it is not an exhaustive list.

Overall, the 21 CFR Part 11 compliant system should be able to ensure the authenticity, integrity, trustworthiness, and reliability of electronic records and signatures.

Read on to learn about the key requirements.

System Validation

Companies must validate their systems to ensure accuracy, reliability, consistent intended performance, and the ability to identify invalid or altered records, as stated in 21 CFR 11.10(a).

When implementing a new system or upgrading an existing one, it is important to take into account computer system validation.

This means that regular system software validation checks must be conducted, ensuring that all elements of your system work as intended. Additionally, you must record validation testing results.

Undertaking software validation can be a daunting task for Life Science companies, especially considering that it may not align with their core expertise.

At SimplerQMS, we alleviate this concern by providing a fully validated solution according to ISPE GAMP5.

This means that we take care of all the software validation for you without any additional expenses, resources, or time commitments on your part.

The software is regularly revalidated every time a new version is released or standard updates are applied, eliminating the need for our customers to conduct validation activities.

You can read our article to understand more about QMS software validation and when it is needed.

Record Generation

Section 21 CFR 11.10(b) specifies that compliant systems must be able to generate accurate and complete copies of records for inspection, review, and copying by the FDA.

A compliant system should have the capability to generate and export copies of stored records within the system.

Moreover, it should also be able to provide both electronic copies and paper copies or printouts.

For a more in-depth explanation of requirements for electronic records, please refer to our 21 CFR Part 11 compliant electronic records guide.

Audit Trails

As outlined in 21 CFR 11.10(e), the system should be able to create a secure audit trail that chronologically documents any changes made to electronic records.

Audit trails provide evidence, enabling companies to track any modifications made to electronic records, including who made the changes, when they made them, and what they changed.

For example, in the SimplerQMS software, any record creation, modification, or retiring is automatically stored in a history file. This file cannot be modified by users and is retained for as long as necessary.

Here, we briefly discussed audit trails. If you want to learn more, please read the full article about the 21 CFR Part 11 audit trail requirements.

Operational Controls

As per 21 CFR 11.10(f), the system should have operational checks designed to verify and ensure that the sequence of events is followed correctly. As a result, it eliminates the possibility of errors or fraudulent activities in electronic records.

21 CFR Part 11 compliant software should enable monitoring and controlling procedures through the phase-gate process. This workflow ensures that appropriate personnel create, review, and approve records.

The illustration above shows key steps in the quality document creation and approval workflow within SimplerQMS software.

This process is done through an automated workflow, where documents move from one phase to another in a specific order.

In this example, the document cannot be edited after approval. In case a change is needed, a change request must be created.

Security Controls

As per 21 CFR 11.10(g), systems should have authority checks to ensure that only authorized individuals can:

• Use the system functions
• Electronically sign a record
• Access the computer system input or output device
• Modify a record
• Perform assigned tasks in the system.

To ensure secure authentication and authorization, SimplerQMS integrates with Microsoft Entra ID (previously known as Microsoft Azure Active Directory), controlling user access to the system.

We establish a clear one-to-one relationship between authorized individuals and their login accounts by providing unique identification codes and password combinations. This approach guarantees that each employee has only one user account, promoting system security and user accountability.

Check out our article dedicated to 21 CFR Part 11 password requirements to learn more about controls for identification codes and passwords.

Personnel Training

21 CFR Part 11.10(i) emphasizes the importance of ensuring that all system users have the necessary education, training, and experience to carry out their designated tasks effectively.

This means that each system user should be trained to perform their assigned tasks. Furthermore, training should be well documented, allowing auditors to review the operational audit trail and cross-reference with training logs.

At SimplerQMS, we provide a comprehensive training program for utilizing the electronic record and signature system.

Upon successful completion of the training, we issue training certificates as proof of qualification.

This helps ensure that all users are aware of how to use the system to perform their assigned tasks confidently.

Electronic Signatures

As specified in 21 CFR 11.50, the system should capture signature information associated with the signing.

A compliant electronic signature must contain the following elements:

• The printed name of the signer
• The date and time when the signature was executed
• The meaning associated with the signature

Furthermore, electronic signatures and handwritten signatures on electronic records must be securely linked to their corresponding records as outlined in 21 CFR 11.70. This prevents anyone from removing, copying, or transferring the signature to fake a record.

For a more detailed explanation of electronic signatures, please refer to our 21 CFR Part 11 compliant electronic signatures guide.

What Are the Key Benefits of Using a 21 CFR Part 11 Compliant System?

Using a 21 CFR Part 11 compliant system offers numerous benefits.

Below are some key benefits you can expect.

Improves Data Integrity

A 21 CFR Part 11 compliant system ensures the integrity of electronic records, reducing the risk of data tampering, loss, or unauthorized modifications. This promotes accurate and reliable data throughout the record lifecycle.

Regulatory Compliance

Companies can ensure they meet the 21 CFR Part 11 requirements for electronic recordkeeping and eSignatures, mitigating the risk of regulatory action.

Curious about the common FDA regulatory actions?

Check out our article on 21 CFR Part 11 noncompliances to find out the most common compliance issues, how to avoid them, and possible FDA enforcement actions in case of major non-compliances.

More Efficient Workflow Processes

Electronic recordkeeping workflow and electronic signature processes become more streamlined. This reduces the time, resources, and manual effort, enabling companies to achieve operational excellence.

Streamlined Collaboration

A compliant system enables secure electronic collaboration and remote access.

It supports collaboration and information sharing among authorized users across departments and locations. The system ensures a controlled environment for project collaboration and information exchange.

Improved Auditability

Electronic records and signatures can be easily tracked in time-stamped and computer-generated audit trails, reducing the risk of errors in the documentation. This enables traceability and accountability and facilitates accurate investigation if necessary.

Increased Security

The regulatory requirements emphasize robust security measures, including access controls, user authentication, and data encryption. A compliant system helps protect sensitive information from unauthorized access, ensuring data confidentiality.

Simplified Recordkeeping

A compliant document management system eliminates the need for paper-based records, reducing storage costs. Electronic records can be easily managed, accessed, and retrieved when required, improving data accessibility and long-term retention.

How Does SimplerQMS Comply With 21 CFR Part 11 Requirements?

The most straightforward approach to achieving compliance with 21 CFR Part 11 is implementing a system compliant with 21 CFR Part 11, out-of-the-box, like SimplerQMS.

SimplerQMS complies with all requirements of the 21 CFR Part 11. Here are some of its key capabilities that help achieve compliance.

Electronic Signatures

SimplerQMS provides 21 CFR Part 11 compliant electronic signatures. Signatures are linked to their respective records, ensuring they cannot be excised, copied, or transferred to falsify an electronic record.

The video below shows an example of how 21 CFR Part 11-compliant electronic signatures and automated workflows work in SimplerQMS.

Audit Trails

The SimplerQMS system maintains detailed audit trails that capture all user actions in electronic records.

The system logs all record creation, modification, archiving, and access activities.

Audit trails are time-stamped and cannot be modified.

System Access Controls

Our software includes appropriate system access controls, such as user authentication, password controls, and role-based access. This ensures that only authorized individuals have access to electronic records and signatures.

Record Retention

The software enables records to be retained in a secure and cloud-based system for the required period.

This allows records to be always readily accessible from anywhere.

System Training

SimplerQMS provides customer training to ensure proficient usage of our software. We provide comprehensive implementation training for all QMS modules.

Customers have the flexibility to request additional training or refresher sessions as needed. Initially, training takes place in a dedicated environment, allowing users to gain confidence before transitioning to the actual company’s software environment.

In addition, companies can streamline their own training. We offer a training management module that facilitates efficient employee training, including onboarding new team members. With features such as training assignments, notifications, reminders, and the ability to create quizzes, our platform empowers you to manage and assess training effectiveness effectively.

Secure Data Storage

SimplerQMS provides secure data storage capabilities that comply with 21 CFR Part 11. The software ensures that all electronic records are stored securely and protected, with access restricted to authorized personnel only.

Controlled Document Management

The system offers a streamlined solution for managing controlled documents. It allows users to manage document versions, access, and distribution easily.

SimplerQMS is more than a 21 CFR Part 11 compliant system.

We provide a complete eQMS software solution designed for Life Sciences. SimplerQMS offers all QMS modules, such as document management, change control, employee training, CAPA management, audit management, and much more.

By using SimplerQMS, Life Science companies can streamline quality management processes, comply with 21 CFR Part 11, and simplify the journey towards compliance with many other Life Science requirements, such as ISO 13458, GxP, ISO 9001, FDA 21 CFR Part 210, 211, and 820, ICH Q10, EU MDR and IVDR, and others.

If you are considering implementing an eQMS solution but need assistance understanding its benefits, we recommend downloading our eQMS Business Case template.

This tool offers a framework for assessing the value of an eQMS specifically for your company. It can support you in presenting your findings to management.

By constructing a comprehensive business case, you can identify the potential return on investment (ROI), cost savings, increased efficiency, and compliance with regulations like 21 CFR Part 11.

Final Thoughts

The 21 CFR Part 11, enforced by the FDA, establishes electronic records and signature requirements. Its purpose is to ensure the trustworthiness and reliability of such records and signatures.

Life Science companies adopt document management and QMS software solutions that comply with 21 CFR Part 11 requirements to ensure compliance.

SimplerQMS stands out by providing a cutting-edge QMS software solution with robust document management capabilities that fully complies with 21 CFR Part 11.

We invite you to book a free demo with one of our experts to see how SimplerQMS can ensure compliance with 21 CFR Part 11 and streamline your quality management processes.

The post 21 CFR Part 11 Requirements [Explained] appeared first on SimplerQMS.

To help companies stay on top of regulatory compliance, we have examined official FDA data, identified the most common 21 CFR Part 11 non-compliances, and given best practices for avoiding them.

One way to ensure compliance with 21 CFR Part 11 is to use a modern Electronic Quality Management System (eQMS) with built-in features and functionality to support FDA requirements.

SimplerQMS provides an eQMS software solution that is fully compliant with 21 CFR Part 11 and tailored to the specific needs of Life Science companies. Book a personalized demo of SimplerQMS to see how your company can benefit from it and make 21 CFR Part 11 compliance easier.

This article covers the following topics:

• Common 21 CFR Part 11 Compliance Issues
• Best Practices to Avoid 21 CFR Part 11 Noncompliances
• Consequences of 21 CFR Part 11 Noncompliances
• Achieve 21 CFR Part 11 Compliance Excellence with SimplerQMS

Common 21 CFR Part 11 Compliance Issues

To gain insight into the most common 21 CFR Part 11 compliance issues for our analysis, we used the official Food and Drug Administration (FDA) Data Dashboard from 2016 to 2020.

Based on the analysis of the data, we identified the five most common problem areas with the most citations:

1. Audit trails: 14 inspection citations.
2. Records retention period: 8 inspection citations.
3. System access controls: 8 inspection citations.
4. System validation: 7 inspection citations.
5. System documentation control and Signature record linking: 4 inspections citations each.

Read our analysis below for a more detailed explanation of the FDA data.

General Analysis of Inspections

During the analyzed period, 14 inspections were conducted for domestic companies in the United States. In contrast, foreign companies underwent only eight inspections.

Upon analyzing the final classification of noncompliance identified during the inspections, it becomes apparent that 18% of the inspection results were classified as No Action Indicated (NAI). This indicates that no objectionable conditions or practices were found during the inspection.

The majority of the inspection were classified as Voluntary Action Indicated (VAI).

This indicates that conditions or practices that are not entirely following the regulation were found. Still, the FDA is not yet prepared to take or recommend any administrative or regulatory action. This classification represented 73% of the inspection results.

Only a small proportion of inspections, 9%, were classified as Official Action Indicated (OAI), indicating the need for regulatory and/or administrative actions by the FDA.

The final classification of inspections by industry type showed that the pharmaceutical drug industry had the most inspections during the analyzed period. This industry accounted for 58% of all audits.

Most of the inspections within the Drugs industry resulted in NAI or VAI classifications, indicating that only a small percentage of inspections led to regulatory or administrative actions.

The Devices and Food/Cosmetics industries also had no inspections classified as OAI during the analyzed period.

In the Veterinary industry, while most classifications were VAI, almost half of the results were OAI, indicating the need for regulatory actions by the FDA.

General 21 CFR Part 11 Noncompliances

From the chart above, it is clear that between 2016 and 2020, 72% of citations for 21 CFR Part 11 noncompliance were related to section 11.10. This section pertains to electronic records, specifically the controls for closed systems.

We can also highlight sections 11.70 for signature and record linking and 11.300 for controls for identification codes and passwords, each representing 6% of the noncompliance issues.

The remaining sections, which cover topics such as electronic signature components and controls, account for 3 to 5% of the total identified noncompliances.

21 CFR Part 11 Section 11.10 Noncompliances

Upon closer analysis of section 11.10, we identified the specific requirements that are most commonly associated with noncompliance.

In the analyzed period, the main compliance issue with closed system controls was related to section 11.10(e). This section refers to using secure, computer-generated, time-stamped audit trails, representing 31% of the citations.

Next, there is almost an equal percentage of citations related to compliance issues related to:

• Section 11.10(a): System validation with 15%.
• Section 11.10(d): System access control with 17%.
• Section 11.10(c): Records retention period with 17%.

Another noteworthy section is 11.10(k), which pertains to system document control and accounts for 9% of total citations.

Followed by section 11.10(f) on operational system checks, which represents 5% of citations.

Additionally, 2% of the citations were related to noncompliance issues in other sections:

• Section 11.10(g): Authority checks.
• Section 11.10(h): Device checks.
• Section 11.10(j): Written policies.

Notably, in the analyzed data, section 11.10(b) regarding the ability to produce copies of records and make them available for FDA review and inspection did not receive any citations.

Proactively addressing these common issues can help Life Science companies avoid regulatory and administrative actions and ensure compliance with 21 CFR Part 11.

One effective solution is implementing robust Document Management or QMS software solution that is fully compliant with the FDA 21 CFR Part 11, like SimplerQMS.

Best Practices to Avoid 21 CFR Part 11 Noncompliances

There are several best practices that Life Science companies can implement to avoid some of the most common compliance issues related to 21 CFR Part 11.

Listed below are some examples of best practices to improve compliance. We will also provide examples of how an eQMS solution follows these practices and help companies ensure compliance with 21 CFR Part 11.

Establish a Robust Audit Trail System

Companies should establish an audit trail system that provides accurate and complete information on all changes made to electronic records. This includes the date and time of each change, the identity of the individual who made the change, and the reason for the change.

The audit trail should be secure, computer-generated, time-stamped, and readily available for review by the FDA.

Audit trails are automatically generated in the SimplerQMS software solution, ensuring all data required as per 21 CFR Part 11 is captured and available for review at all times.

Here we provided a brief overview of best practices for the audit trail system. For more comprehensive information on this topic, please refer to our 21 CFR Part 11 audit trail requirements article.

Implement Appropriate System Access Controls

Companies should implement system access controls to ensure that only authorized individuals can access electronic records and signatures. These controls can include user authentication, password controls, and role-based access.

For example, SimplerQMS integrates with Microsoft Entra ID (previously known as Microsoft Azure Active Directory) to control user access to the system, ensuring secure authentication and authorization.

We provide unique identification codes and password combinations to establish a clear one-to-one relationship between authorized individuals and their login accounts. Additionally, we ensure that each employee has only one user account.

To ensure secure access to electronic records systems, companies must comply with identification code and password requirements. You can learn more about this topic by reading our 21 CFR Part 11 password requirements article.

Ensure Proper Record Retention

Companies should establish records for retention procedures that include the length of time electronic records must be retained and the format in which they should be stored.

Using modern QMS solutions, like SimplerQMS, allows companies to store records in a cloud-based system. This ensures that documents are always secure and readily available anywhere.

In the SimplerQMS system, document collections can be created to facilitate the organizing of relevant records for retention, audits, and regulatory submissions.

The search feature allows you to match keywords in both document titles and content, simplifying the process of retrieving records.

Additionally, if there is a need to restore prior versions of documents, a roll-back function is readily available to facilitate the process.

Establish Clear Standard Operating Procedures (SOPs)

Develop and maintain procedures and written policies for managing electronic records and signatures, as well as for the operation of the QMS system.

Ensuring that employees are familiar with and follow the policies and procedures consistently is essential.

Using a document management system, such as SimplerQMS, companies can easily create and maintain the policies and procedures documentation. It is possible to assign documents to relevant people for review and approval.

The software also facilitates employee training by easily relating SOPs to other documents and training material.

Share Copies of Records With the FDA

Companies should also ensure the creation of copies of records. These copies need to be accurate and complete, maintaining all information from the original record.

Moreover, copies of records must be accessible only to authorized individuals and available to FDA inspections as necessary.

With the SimplerQMS solution, it is easy to create copies of records. The system allows converting and exporting documents with just a few clicks. It also has a controlled print feature to keep track of all printouts.

Conduct Regular Validation Testing

Regular validation testing of electronic record systems ensures they function as intended. It should be conducted periodically and after any significant changes or upgrades to the system.

SimplerQMS software is validated according to ISPE GAMP5, a risk-based approach to computer systems.

The software is regularly revalidated by SimplerQMS every time a new version is released, or standard updates are applied, eliminating the need for customers to conduct validation activities.

Keep Electronic Signatures Accessible and Secure

Companies must ensure that electronic signatures are unique to each user and cannot be copied or reused. Electronic signatures must also be linked to records and include the signer’s identity, date, time, and meaning.

Electronic signatures in SimplerQMS are automatically linked to their respective records, preventing them from being removed, duplicated, or transferred to falsify any document.

The system also captures and displays all signature information at the bottom of all documents.

This section provided a concise overview of electronic signatures under 21 CFR part 11. For a more in-depth understanding, we recommend reading our article on 21 CFR Part 11 compliant electronic signatures.

Ensure Proper Training and Documentation

Companies should ensure that employees working with electronic records and signatures receive proper training on the relevant policies and procedures. Keeping a record of training completion for compliance purposes is also a must.

Upon becoming a customer of SimplerQMS, our implementation team provides extensive training to users and issues training certificates.

Using the SimplerQMS solution also helps streamline employee training. The software allows you to create learning rules and assign relevant procedures and documents for specific training purposes.

The system automatically sends notifications and reminders about the training assignments, tracks the training status, and creates re-training assignments when specific documents related to training are updated.

Additionally, Training Managers can create quizzes to evaluate the effectiveness of the training and do much more.

Consequences of 21 CFR Part 11 Noncompliances

Noncompliance with 21 CFR Part 11 may result in advisory actions.

But FDA enforcement actions can be more severe if there are additional violations.

The consequences become more severe and extensive as noncompliance increases in severity and frequency.

Some of the enforcement actions listed in the FDA Regulatory Procedures Manual are the following:

Advisory actions

• Untitled Letter: This letter is sent to regulated companies to address minor violations that do not meet the regulatory significance threshold for a Warning Letter.
• Warning Letters: These are notices sent to individuals or companies advising them about specific violations with regulatory significance. The letters ask for a written response on the actions that will be taken to fix the problem.

Administrative actions

• Citations: This is a notice given to a company accused of violating the regulation. The notice allows the company to share its views in writing or orally before the United States institutes any criminal proceeding.
• Administrative Detentions: The FDA can hold adulterated or misbranded products and prevent them from reaching the marketplace.
• Civil Money Penalties: The FDA may impose monetary penalties on companies for violating food, drugs, and cosmetics regulations.

Judicial actions

• Seizure: Occurs when the FDA takes action against a product that violates regulations by being a significant or serious risk to the product user. The goal is to remove these products from the market.
• Injunction: This is a legal process used to stop or prevent a violation of the regulations. It is often used to stop the sale or distribution of noncompliant products and address the issue’s reason.
• Criminal Prosecution: The FDA’s Office of Criminal Investigation investigates illegal activities involving FDA-regulated products and arrests those responsible. People who violate the regulation may have to go to court and receive punishment according to the law of the United States.

Achieve 21 CFR Part 11 Compliance Excellence with SimplerQMS

Achieving compliance excellence is made easier and more effective with the use of the 21 CFR Part 11 compliance software solution.

SimplerQMS offers a comprehensive QMS software solution that integrates all core Life Science QMS modules into a single system:

• Document Management
• Change Control Management
• Training Management
• Supplier Management
• Audit Management
• Nonconformance/Deviation Management
• CAPA Management
• And more

To gain a better understanding of the benefits that SimplerQMS can offer, download our eQMS Business Case template.

Using this template, you can identify the economic advantages of implementing an eQMS and create a compelling business case to present your findings to management or the board.

Final Thoughts

Many companies still face challenges regarding 21 CFR Part 11. However, by examining where common problems arise, companies can proactively address potential issues.

Upon closer analysis, it is evident that the most common noncompliance issues regarding 21 CFR Part 11 are related to electronic records, particularly controls for closed electronic systems.

To address these challenges, an electronic document storage system or eQMS, such as SimplerQMS, allows companies to comply with the requirements of 21 CFR Part 11 effortlessly.

At SimplerQMS, we provide a complete eQMS solution made for the needs of Life Science companies that fully complies with 21 CFR Part 11.

Request a demo of the SimplerQMS solution, talk with our experts, and learn how we can help your company get up and running with an eQMS that will help your company comply with 21 CFR Part 11.

The post 21 CFR Part 11 Noncompliances (And How to Avoid Them) appeared first on SimplerQMS.

This article explains the difference between open and closed systems as per Title 21 CFR Part 11. It discusses the specific compliance requirements and provides examples to help you better understand these types of systems.

Life Science companies are increasingly adopting digital closed systems, like Document Management Systems and Quality Management System (QMS) software solutions. They limit access to authorized personnel and track all user actions within the system, among other features.

SimplerQMS provides a comprehensive eQMS solution tailored for Life Sciences companies that is also fully compliant with 21 CFR Part 11. Book a personalized demo of SimplerQMS to see how our solution can fast-track your compliance efforts by providing a full 21 CFR Part 11 compliance.

Explore the topics below to gain a better understanding of open and closed systems:

• What is an Open System?
• What is a Closed System?
• Differences Between Open and Closed Systems
• Streamline Quality and Compliance with Closed eQMS Software

What is an Open System?

An open system refers to an environment where individuals responsible for the content of electronic records on the system do not control system access, according to 21 CFR 11.3(b)(9).

This means that anyone can create a system user account on their own without needing approval or access granted by an administrator.

While this may seem convenient, it can also create security risks and make it difficult to ensure the accuracy and reliability of electronic records.

Companies must be careful when using open systems to manage electronic records and ensure that they have adequate controls and procedures in place to ensure the security and accuracy of their data.

Requirements for Open Systems

21 CFR Part 11.30 outlines the controls for open systems.

This includes all requirements also applicable to closed systems and some additional measures, such as:

• Encrypting documents: This is the process of making data unreadable using a complex algorithm, making it secure and protected from unauthorized access. It can be used to protect sensitive data and intellectual property in electronic records. Encrypting documents ensures that only authorized personnel have access to the information.
• Using digital signature standards: The standard specifies the algorithms that can be used to generate a digital signature. These are a set of rules and parameters that allows tracking signature information to verify the signer’s identity. For instance, public key infrastructure and multi-factor authentication.

Companies need to have procedures and controls in place to make sure electronic records are accurate and secure from their creation until their receipt.

Examples of Open Systems

Two examples of open systems you might be familiar with are email and cloud storage services.

Email is a messaging system that allows users to send and receive messages through an electronic platform. Anyone can create an email account on various free email providers.

However, when using an open email system, companies must take measures to ensure that the emails sent or received are accurate, authentic, and confidential.

This can be achieved by using strong passwords, setting up multi-factor authentication, and avoiding sharing confidential information over email, for example.

Cloud storage services are online platforms that allow users to store, share, and access documents and data remotely. These services are accessible to anyone who creates an account. There are typically no limitations on the types of files that can be stored or shared.

It is essential to take steps to ensure the accuracy and security of any electronic records stored in a cloud storage system. This can include encrypting files and restricting access to authorized personnel via access links.

What is a Closed System?

A closed system, as defined by 21 CFR 11.3(b)(4), is an environment where system access is controlled by persons responsible for the content of electronic records stored in the system.

In other words, in a closed system, only authorized personnel are granted access to the system. Their actions are monitored and recorded in an audit trail.

This type of system is frequently used in Life Science industries to restrict access to sensitive information and ensure data integrity.

Requirements for Closed Systems

21 CFR Part 11.10 specifies the requirements for controls for closed systems.

The following procedures and controls must be in place according to each section of the part of the regulation:

• 21 CFR 11.10(a): Computer system validation systems for accuracy, reliability, and intended performance.
• 21 CFR 11.10(b): Ability to generate accurate and complete copies of records for inspection, review, and copying by the FDA.
• 21 CFR 11.10(c): Protect records for accurate retrieval throughout the retention period.
• 21 CFR 11.10(d): Limit system access to authorized personnel.
• 21 CFR 11.10(e): Use secure, computer-generated, and time-stamped audit trails to record operator entries and actions on electronic records.
• 21 CFR 11.10(f): Use operational system checks to make sure steps and events happen in the correct order.
• 21 CFR 11.10(g): Use authority checks to ensure only authorized personnel use the system and electronic signatures.
• 21 CFR 11.10(h): Use device checks to ensure the data and operational instructions are reliable and accurate.
• 21 CFR 11.10(i): Ensure personnel have the education, training, and experience to use electronic record systems.
• 21 CFR 11.10(j): Establish and adhere to written policies that hold individuals accountable for actions initiated under their electronic signatures.
• 21 CFR 11.10(k): Implement controls over systems documentation distribution, access, use, revision, and change.

When using closed systems for electronic records, it is necessary to have controls and procedures in place to ensure the integrity and confidentiality of records.

Moreover, they should prevent the signer from denying the authenticity of the signed document.

Examples of Closed Systems

Some systems are typically closed, as they are designed to manage specific business processes within a company and are not intended to be accessible or modifiable by external parties.

Examples of closed systems include Document Management Systems (DMS) and Quality Management System (QMS) software solutions.

DMS can help companies manage electronic documents, such as standard operating procedures, batch records, and analytical test reports.

QMS solutions help companies manage quality-related activities such as deviation or nonconformances, change controls, audits, suppliers, employee training, CAPA workflows, and so on.

Here are some other examples of typically closed systems:

• Enterprise Resource Planning (ERP)
• Customer Relationship Management (CRM)
• Product Lifecycle Management (PLM)
• Laboratory information management systems (LIMS)
• Electronic laboratory notebooks (ELN)
• Clinical trial management systems (CTMS)
• Manufacturing execution systems (MES)
• Electronic batch record (EBR) systems
• Electronic data capture (EDC) systems for clinical trials
• Regulatory information management System (RIMS) for managing regulatory submissions

Differences Between Open and Closed Systems

The main difference between open and closed systems is system access control.

In a closed system, an administrator needs to grant user access for anyone to work within the system. In contrast, users can create their own user accounts in an open system. Although both open and closed systems have many similar requirements, open systems have some additional requirements.

It is important to note that all requirements listed under section 11.10 apply to both open and closed systems.

However, open systems must also comply with additional requirements in section 11.30.

Therefore, companies need to understand their system and be aware of the specific requirements for open and closed systems under 21 CFR Part 11 to ensure compliance.

This article only discusses open and closed systems and their requirements. If you are interested in learning more about achieving overall compliance, we recommend reading our article on 21 CFR Part 11 compliance.

Streamline Quality and Compliance with Closed eQMS Software

SimplerQMS offers a comprehensive, closed Electronic Quality Management System (eQMS) solution with integrated modules designed specifically for Life Science companies.

With SimplerQMS, Life Science companies can easily streamline their quality processes and maintain 21 CFR Part 11 compliance.

In addition to being a 21 CFR Part 11 compliant system for electronic records management with electronic signatures, SimplerQMS provides various Life Science QMS modules such as change control, employee training, audit management, supplier management, CAPA, and more.

To explore the benefits of SimplerQMS in greater detail, we invite you to download our eQMS Business Case template.

This template can help you evaluate the financial benefits of implementing an eQMS and prepare a convincing business case for your management or board of directors.

Final Thoughts

Life Science companies have the option to utilize either open or closed systems to handle electronic records and signatures according to 21 CFR Part 11.

The main difference between them is the level of control over system access. Closed systems have specific controls and procedures in place to ensure data integrity.

Moreover, open systems must comply with these requirements and require additional measures such as encryption and digital signature standards.

For companies seeking to manage their quality systems efficiently and achieve compliance with regulations, SimplerQMS offers comprehensive QMS software that is a closed system and fully compliant with 21 CFR Part 11.

Our software enables companies to streamline their quality system management and comply with FDA requirements for electronic records and digital signatures. To learn more about SimplerQMS’s features and benefits, schedule a demo and speak with one of their system experts.

The post 21 CFR Part 11 Open vs Closed System: What is the Difference? appeared first on SimplerQMS.

These requirements are relevant for Life Science companies that operate in the United States market, and that chose to use electronic records and signatures in place of paper records and handwritten signatures.

One of the specific requirements outlined in 21 CFR Part 11 is the need for passwords.

These password requirements aim to ensure that access to electronic records and using digital signatures is limited to only authorized individuals.

This article will discuss 21 CFR Part 11 password requirements, provide best practices for password creation and management, and explain how SimplerQMS complies with these requirements.

SimplerQMS provides an eQMS software solution specifically designed for Life Science companies and ensures full compliance with 21 CFR Part 11. Schedule a personalized demo of SimplerQMS and talk to our experts to learn more about our solution.

Learn about 21 CFR Part 11 password requirements by exploring these topics:

• What are 21 CFR Part 11 Password Requirements?
• Best Practices for Password Creation and Management
• How SimplerQMS Meets 21 CFR Part 11 Password Requirements

What are 21 CFR Part 11 Password Requirements?

The FDA 21 CFR Part 11 specifies password security and management requirements in electronic record and signature systems.

Compliance with these requirements is essential for Life Science companies operating in the US market and opting to use electronic records and digital signatures. The FDA requires computerized systems to maintain accurate and secure electronic records.

Major noncompliance with FDA requirements can result in significant financial penalties, warning letters, product recalls, and damage to a company’s reputation.

The following sections will outline the password requirements according to 21 CFR Part 11.

Implement Unique Passwords (Section 11.300(a))

The system should have controls to ensure unique password and identification code combinations for authorized users, as outlined in section 21 CFR 11.300(a).

If two individuals were to share the same identification code and password, it would be impossible to determine who executed a digital signature or changed an electronic record. This could lead to inaccuracies, errors, and potential regulatory violations.

Control measures for having unique passwords might include using encryption and implementing password policies that enforce complex passwords.

Prevent Password Aging (Section 11.300(b))

Section 21 CFR 11.300(b) states that it is important to ensure that identification codes and passwords are periodically checked, recalled, or revised to maintain the security and integrity of electronic records and signatures.

These checks help ensure that passwords and identification codes are still valid and have not been compromised in any way.

One way to achieve this is by requiring employees to change their passwords after a certain period, for instance, every 90 days. Frequently changing passwords reduces the risk of unauthorized access to electronic records by people who obtain the password illegally, like hacking.

Additionally, procedures should be in place to immediately deactivate or update identification codes and passwords if an employee leaves the company or suspects they may have been compromised.

Ensure Loss Management Procedures (Section 11.300(c))

Section 21 CFR 11.300(c) states that loss management procedures should be followed to deauthorize any device that keeps or generates identification codes or password information that has been lost, stolen, or potentially compromised.

Once a device is no longer authorized, the system should be able to issue password replacements using suitable and rigorous controls.

It is important to note that loss management procedures should be reviewed and updated regularly to ensure their effectiveness.

In addition, all employees should be trained on the proper procedures for reporting lost or stolen passwords to reduce the risk of unauthorized access.

Avoid Unauthorized Use of Passwords (Section 11.300(d))

The system should have transaction safeguards in place to prevent the unauthorized use of passwords and identification codes as per section 21 CFR 11.300(d).

Transaction safeguards may include various security measures, such as encryption, access controls, multi-factor authentication (MFA), and other security measures that protect data during transmission and storage.

It is also important to promptly detect and report unauthorized system access attempts to the security unit.

Perform Password Device Testing (Section 11.300(e))

Section 21 CFR 11.300(e) specifies that testing devices containing identification codes or password information is required to ensure their proper functioning and detect any potential alterations.

This includes devices such as tokens and cards that are used to generate or store identification codes and passwords.

Initial testing is important to ensure the device is functioning properly before use. Periodic testing is also necessary to ensure that the device continues functioning correctly and has not been compromised since the initial testing.

While this article only discusses the password requirements specified in 21 CFR Part 11, it is worth noting that several other requirements are outlined in this part of the regulation.

We suggest reading our 21 CFR Part 11 compliance article if you want to further your knowledge on the subject.

Best Practices for Password Creation and Management

Following best practices for creating and managing passwords is essential to maintaining the security and integrity of electronic records and digital signatures.

Here are some examples of best practices to improve password security:

Create Complex Passwords

It is important to implement rules for strong and complex passwords. Additionally, prevent multiple people from using the same login information by ensuring that each person has at least two distinct identification components such as an identification code and password.

Establish a password procedure that requires users to:

• Create complex and unique passwords with a mix of uppercase and lowercase letters, numbers, and special characters.
• Avoid easily guessable passwords, such as common words, sequential numbers, or easily identifiable information.
• Have a minimum password length, typically at least eight characters or more.

For instance, SimplerQMS software uses Microsoft Entra ID (previously known as Microsoft Azure Active Directory), and one of its many uses is to ensure strong and secure passwords.

The system validates and manages the uniqueness of identification codes and passwords and ensures that no two individuals can have the same combination of code and password to access the system.

Periodically Update Passwords

You should regularly check and update identification codes and passwords. This is important to prevent password aging and maintain security.

One way to ensure this is to establish a procedure that requires users to change their passwords periodically. This measure helps ensure that outdated passwords are promptly updated, improving overall security.

Using SimplerQMS, for example, the system has procedures for password expiry in place. Passwords are automatically required to be updated every three months. Furthermore, the past 42 passwords are saved and cannot be reused.

Handle Lost and Stolen Passwords

It is important to have a plan of action if the devices that store or generate identification codes and passwords are lost or compromised.

A practical way to do this is by asking users to report any theft or loss of their authentication credentials as soon as possible and quickly disabling any lost device. When issuing replacements, strict controls should be in place to prevent unauthorized access and keep the new devices secure.

For example, SimplerQMS connects with Microsoft Entra ID to centrally control access to the system and applications, improving visibility and control of loss management procedures. Via Microsoft Entra ID, it is possible to deauthorize users and reset passwords if necessary.

Use Transaction Safeguards

Implement transaction safeguards to prevent unauthorized use of identification codes and passwords.

These security measures might include:

• Account lockout policies, with a limited number of failed login attempts.
• Multi-factor authentication (MFA) for an additional layer of security.
• An automated system that detects failed login attempts or unusual login patterns, such as login from unfamiliar locations.
• Detect and report any unauthorized attempts to use identification codes or passwords.
• Antivirus software scans files to detect and remove any malicious code, such as viruses.

For example, you could automatically lock computer screens with a password-protected screen saver after 10 minutes of inactivity to prevent unauthorized access and data manipulation.

And/or employ multi-factor authentication (MFA) to further secure access to our system, requiring users to provide supplementary verification in addition to their login credentials.

Test and Monitor Devices

Conduct a periodic test of devices that generate login credentials to ensure they work as intended.

Provide Training to Employees

Providing regular training to educate employees about password security can help ensure that users understand and follow relevant requirements.

A practical approach is to instruct on how to use the electronic records and electronic signature system, how to create strong passwords, and best practices for password management.

For instance, using Training Management capabilities in SimplerQMS, you could create learning rules and attach 21 CFR Part 11 related procedures and documents for learning. Automatically assign training to relevant personnel, send notifications, and reminders, and monitor training status.

As a part of the training, you could also create quizzes to assess training effectiveness.

How SimplerQMS Meets 21 CFR Part 11 Password Requirements

SimplerQMS offers a comprehensive Life Science QMS software solution that meets the requirements of 21 CFR Part 11.

SimplerQMS complies with the password requirements outlined in 21 CFR Part 11 through:

• Managing identification codes and passwords and preventing duplicate identification codes and password combinations.
• Connects to Microsoft Entra ID and enforces password strength and expiration rules.
• Saving the user’s last 42 passwords and prohibiting their reuse.
• Automatically expiring passwords every three months and requiring their update.
• Implementing procedures for complex password creation to enhance password security.
• Preventing unauthorized access by anyone other than the authorized user.
• Performing testing and validation processes to ensure the system performs as intended.

In addition to a secure and 21 CFR Part 11 compliant documentation system, SimplerQMS provides all Life Science QMS modules. Besides document control and management, we offer modules for change, non-conformance and deviation, CAPA, training, supplier management, and more.

If you are unsure of the advantages of having SimplerQMS consider downloading our eQMS Business Case template.

By utilizing this resource (with pre-configured spreadsheet and presentation slides), you can identify the value an eQMS can bring to your company. Then present your findings to the management or board.

Download the template below to make a compelling case for implementing an eQMS in your company.

Final Thoughts

Essential for Life Science companies operating in the US market, 21 CFR Part 11 is part of FDA regulation that outlines requirements for trustworthy and reliable electronic records and digital signatures.

One of the requirements outlined in 21 CFR Part 11 is the use of passwords to limit system access to electronic records and digital signatures to authorized personnel only.

Many companies have adopted 21 CFR Part 11 compliant electronic Quality Management Systems (eQMS) to manage processes more efficiently and ensure compliance.

SimplerQMS offers a fully 21 CFR Part 11 compliant eQMS software solution specifically designed for Life Science companies.

Book a personalized demo of SimplerQMS to see it in action and talk to our system experts about how we can help you streamline quality and compliance processes.

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