The CFR 21 Part 11 is a standard of the United States Food and Drug Administration (FDA). It establishes the requirements and rules for the use of computerized automation systems in the pharmaceutical, biotechnology, and medical device industries. Therefore, it is widely followed all over the world.

The CFR 21 Part 11 guidelines are part of the Good Manufacturing Practices (GMP), and it further reinforces the importance of this international.

Read on and find out all about CRF 21 Part 11, what its key requirements are, and how it helps increase quality and compliance in the Life Sciences industry.

See also: What is IN 134

What is CFR 21 Part 11?

The standard came into existence in 1997 when the FDA created regulations that defined the criteria for the acceptance of electronic/handwritten records and signatures made on electronic documents.

This set of regulations was called Part 11 of Title 21 of the Code of Federal Regulations — better known as 21 CFR Part 11 or CFR 21 Part 11.

Learn about the five main aspects regulated by the CFR below:

Authenticity and Integrity of Electronic Records — Ensure that electronic records used in medicines and devices are authentic, complete, and cannot be altered without proper authorization.

Electronic Signatures — Ensure that electronic signatures carry the same legal weight as handwritten signatures, as well as that they are linked to a specific electronic record.

Access Control — Implement systems that manage electronic records, which in turn need to have adequate access control measures in place to protect sensitive information.

Audit Trail — Maintain an audit trail that documents all changes made to electronic records, including who made those changes and when they occurred.

Systems Validation — Validate the systems used to generate, store, and transmit electronic records to ensure their proper functioning.

The structure of CFR 21 Part 11

This CFR is divided into three main parts to facilitate both its understanding and implementation. They are: General Provisions, Electronic Records and Electronic Signatures. Check out more about each one below!

General Provisions — Defines the scope of regulations. For example, it stipulates when and how CFR 21 Part 11 should be implemented, as well as some of the key terms used throughout the regulation.

Electronic Records — Establishes the requirements for the administration of electronic record-keeping systems (whether closed or open). In addition, it presents the requirements for establishing a link between subscriptions and records.

Electronic Signatures — This part of the CFR is divided into three other parts: general requirements for electronic signatures, electronic signature components and controls, and controls for identification codes/passwords.

These electronic signatures are authentications that use encryption systems to verify the user’s identity. Thus, the signature proves the reliability of the system and the document in question.

With this breakdown into three main frameworks, 21 CFR Part 11 aims to clarify the requirements for software validation, audit trails, legacy systems management, record copy maintenance, and record retention. Thus, it provides useful information on what companies need to do to comply with this standard.

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How to comply with CFR 21 Part 11?

As you have already seen, the main objective of CFR 21 Part 11 is to regulate the use of electronic systems — especially those used for digital signatures — in the manufacturing process of products and equipment. This standard applies mainly to companies in the pharmaceutical, biotechnology, and medical device fields.

Therefore, if you want to ensure that your company is compliant with the CFR, you need to pay attention to the main aspects that are dealt with in it. In general, they can be divided into three categories: system validation, audit logging, and record retention and copying.

Each one has its specificities and takes into account the activities and processes of different companies. Depending on the nature of your company’s business, you may need to pay more attention to system validation or audit logging, for example.

To find out which of the key aspects included in 21 CFR Part 11 you need to focus on, check out the items below and consider how each of them is present in your operation.

Systems validation

System validation: Ensure that your system is properly validated to ensure its effectiveness and compliance with the specific rules of the standard.

E-signature policy: Check if there is a policy that assigns full responsibility to the people under your e-signatures.

Data logging and retrieval: Ensure that logs are readily recoverable throughout the retention period should this be necessary.

Data security: Make sure that the data included in the system is encrypted and that its integrity is preserved.

Verification of the source of the data: When necessary, it is also important to verify the validity of the data source or instructions received, ensuring that they are reliable and secure sources.

Access control: Have ways to ensure that only authorized people have access to the system and the electronic signatures contained in it.

Training documentation: Keep a record of training focused on the use of the system. This training needs to be available to system users, developers, IT support staff, and other contributors for whom this access is pertinent.

Audit Trail

Secure and accessible audit log: Maintain a secure audit log that stores the date and time of entries and the actions taken by operators. In addition, this record needs to be available for review and copy by the regulatory body.

Change tracking: Have ways to preserve old electronic records after they undergo some change, in order to strengthen the traceability of the operation.

Details in electronic signatures: Electronic signatures should contain specific information, such as the name of the signer, the date and time of the signature, as well as the purpose of the signature.

Signature protection: Ensure that electronic signatures are securely linked to system records to prevent improper access and forgery, for example.

Change Control: Rely on a formal change control procedure for system documentation.

Unique identification: Electronic signatures should be unique to each individual and never reused.

Identity verification: Have mechanisms in place to verify the subscriber’s identity appropriately. This must occur before the electronic signature is assigned.

Biometric security: In the case of biometric signatures, it is necessary to ensure that they are for the exclusive use of the true owner of each one.

Record retention and copying

ID and password control: The system must have strict controls in place to ensure that each ID code and password is unique to each user.

Passwords with an expiration date: Ensure that passwords expire periodically and undergo regular review.

Reporting of unauthorized attempts: Rely on procedures that report unauthorized attempts to access administration. This needs to happen immediately, for all improper access.

Token and card testing: Perform tests (both initial and periodic) on tokens and access cards to ensure their effectiveness.

Identification and password deactivation: Your system needs to have tools to disable passwords or identification codes that have been compromised or lost.

Recall of codes and passwords: Likewise, have procedures for the recall of identification codes and passwords when the holder of them leaves your company or even when he is transferred to another area/function.

Loss management procedure: Rely on a procedure to handle situations of lost or stolen devices.

Integrity testing: Perform regular checks on the integrity of records to detect any potential unauthorized changes.

Producing copies of electronic records: Create and store these copies, which can be used for regulatory inspections or even ongoing operations if the core system fails. These copies must be in both printed and electronic format (such as PDF, XML, SGML etc.) and must be available to the regulatory body.

How 21 CFR Part 11 Affects Electronic Logging for Life Sciences Companies

CFR 21 Part 11 has a significant impact on Life Sciences companies, particularly those working with regulated products. Among these, pharmaceutical, biotechnology and medical device companies stand out.

The main reflection of the adoption of this standard is precisely to ensure more security, traceability and control in the use of electronic records and passwords. Thus, 21 CFR Part 11 helps prevent failures, streamlines the production process, and protects against fraud.

Learn more about the main ways this CFR helps companies in the sector.

Systems validation: By using the guidelines of CFR 21 Part 11, companies have the best practices they must follow to validate their data management systems. Thus, they can more easily ensure that electronic records are generated/stored accurately and reliably.

Data integrity and security: Organizations can implement robust security measures to protect data integrity, such as access control, encryption, and protection against unauthorized changes.

Ease of undergoing audits: This care helps to maintain an audit record that documents all changes made to electronic records, ensuring data traceability. This way, it is much easier to perform an audit — and your results will be much more satisfactory.

Management of electronic signatures: The standard leads companies to adopt appropriate practices for the use of electronic signatures, ensuring that they are unique, linked to a specific user and that they comply with the most esteemed market requirements.

Training and awareness: Companies start training employees on the requirements of CFR 21 Part 11. Thus, everyone knows good practices that help in daily work, such as creating, modifying, and managing electronic records properly.

Record and document procedures: With these guidelines, there is a duty to develop and maintain comprehensive documentation that outlines the procedures for creating and maintaining electronic records. This brings more security, transparency and efficiency to the operation.

In other words, it is through these precautions and regulations that companies ensure that the data generated and used in research and production are compliant. As a result, corporations increase confidence in the quality and safety of their products, both for internal and external stakeholders.

Conclusion

Understanding CFR 21 Part 11 is essential for companies in the Life Sciences area — even though it deals with a very specific sector within an operation.

This is because by following the rules of this legislation, American companies or companies from other countries strengthen the management of electronic records and passwords. Thus, they have more safety and quality in their products, whether medicines or medical devices.

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