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21 CFR Part 11 Compliance: Complete Guide [free checklist]

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21 CFR Part 11 Compliance: Complete Guide [free checklist]

quotation marks
Tali Kauffmann
Product Marketer at Opvia
12 minute read

Staying compliant with FDA 21 CFR Part 11 is crucial for keeping data accurate and secure in life sciences industries. This guide breaks down everything you need to know about 21 CFR Part 11, including key requirements, common challenges, and practical tips. We'll also provide a comprehensive checklist to help make sure your organisation meets all the necessary standards. Whether you're just starting out or looking to improve your current processes, this article will help you understand the regulation and remain compliant. 

What is 21 CFR Part 11 Compliance?

Definition and Overview

21 CFR Part 11 is a set of rules created by the U.S. Food and Drug Administration (FDA) that outlines how electronic records and electronic signatures should be handled to make sure they are as reliable and trustworthy as their paper counterparts. When a company is compliant with 21 CFR Part 11, it means they’re following these rules and making sure their digital documents are safe and credible.

History and purpose of 21 CFR Part 11

21 CFR Part 11 was introduced in 1997 since more companies in regulated industries like pharmaceuticals, biotechnology, and medical devices were starting to use digital systems.

The main goals of 21 CFR Part 11 are:

  • To set standards for electronic records and signatures so they can be trusted.
  • To make sure electronic records are as good as paper ones.
  • To provide guidelines for secure and traceable electronic systems.

Since its introduction, the regulation has been updated to keep up with new technologies and industry practices, with a major update in 2003.

Basics of 21 CFR Part 11

Key Requirements for Compliance

To comply with 21 CFR Part 11, there are a few important things companies need to do. 

First, they need to validate their electronic systems to make sure everything works correctly and consistently. This means testing the systems to check that they produce accurate and reliable results every time.

Next, companies need to set up reliable, computer-generated audit trails. These trails record every action taken with electronic records, including who made changes, when they were made, and what was changed. 

Security is another big part of compliance. Companies should have procedures to control access to electronic records. Only authorised staff should be able to use the system, sign records, or make changes.

When it comes to electronic signatures, they need to be unique to each person and include the signer’s name, the date and time of signing, and the meaning of the signature (e.g. approval or review). 

Lastly, companies need to make sure electronic records are kept for as long as necessary and are accessible throughout their retention period. The records should be preserved in a way that protects data integrity. 

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Glossary of Key Terms

Electronic records are documents, databases, and other types of information stored digitally. They are the digital versions of paper records.

Electronic signatures are digital versions of handwritten signatures used to sign electronic records. These signatures need to meet certain requirements to be secure and verifiable. 

Validation is the process of ensuring that an electronic system performs as it should. This involves testing the system to make sure it consistently produces accurate results.

Audit trails are secure logs that record all changes made to electronic records. They include details like the date and time of changes, who made the changes, and what exactly was changed. Audit trails track the history of a record and make sure everything is accountable.

Record retention means keeping electronic records for a specific period, during which they must be accessible and protected from unauthorised changes. This ensures records remain available for regulatory reviews and audits.

Comparison with global standards like the EU's Annex 11

21 CFR Part 11 is often compared to other global standards, like the EU's Annex 11. Both aim to secure the integrity of electronic records and signatures, but there are some differences.

While 21 CFR Part 11 applies to all electronic records and signatures under FDA jurisdiction, Annex 11 specifically applies to computerised systems in GxP (Good Practice) environments within the EU. Both require system validation, secure audit trails, and controlled access to records. However, Annex 11 places more emphasis on risk management and the life cycle management of systems.

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Difficulties in achieving compliance

Complying with 21 CFR Part 11 can sometimes be quite challenging. Many companies struggle with understanding the detailed requirements, especially if they're new to digital systems. 

Keeping electronic systems validated, maintaining secure audit trails, and ensuring proper record retention are common issues. Making sure that electronic signatures are secure and verifiable can also be tricky.

Practical tips to overcome these challenges

One of the first steps to overcoming these challenges is to thoroughly understand the requirements of 21 CFR Part 11. Make sure your team knows what’s needed for validation, audit trails, security, and record retention. Regular training sessions can help keep everyone up to date. 

Developing clear procedures for managing electronic records and signatures is also crucial. This means having written guidelines on how to validate systems, maintain audit trails, and handle record retention. Clear procedures help ensure everyone knows what to do and how to do it.

Conducting regular internal audits can help you stay on top of compliance. These audits can identify any gaps or issues that need to be fixed. Regularly reviewing your procedures and systems ensures they remain effective and compliant.

How using an eQMS can help 

Using electronic Quality Management System (eQMS) software can make achieving and maintaining compliance with 21 CFR Part 11 much easier.

Here’s how eQMS can help:

eQMS software often comes with built-in validation protocols, which makes it simpler to ensure compliance. They also automatically generate secure, computer-generated audit trails, ensuring all changes to electronic records are tracked and easily accessible for review.

Managing electronic signatures is also straightforward with eQMS software. The software makes sure that signatures are unique, verifiable, and include necessary details like the signer’s name, date and time of signing, and the meaning of the signature.

When it comes to record retention, eQMS software provides storage for electronic records so that they’re retained for the required period and remain accessible. 

If you’d like to read more about eQMS we’ve written more extensively about this in the article What is an electronic quality management system (eQMS)? 

Or, you can get started with Opvia’s free tier QMS.

21 CFR Part 11 Noncompliance

Consequences of noncompliance

Not following 21 CFR Part 11 rules can really hurt your business.

If you're not compliant, you could face data breaches, lose credibility, and get hit with massive fines. The FDA can send warning letters, and if things get bad enough, they could even recall your products or shut down your operations.

Examples of FDA actions for violations

When companies don’t follow the rules, the FDA steps in. They might start by issuing a Form 483, which points out where you're falling short. If you don’t fix these issues, you could get a warning letter, which is more serious and can become public.

In the worst cases, ongoing noncompliance can lead to the FDA taking even stronger actions. They might seize your products, impose fines, or shut down your operations. For example, if a pharmaceutical company doesn’t properly secure its electronic records, they might get a warning letter outlining the problems. If they ignore it, they could face product recalls or even a halt in production.

21 CFR Part 11 Compliance Checklist

Validation

Making sure your electronic systems are properly validated is crucial. Here’s how to get it right:

  • Plan validation: Figure out what needs to be validated and what success looks like.
  • Conduct tests: Check that the system works as it should.
  • Document results: Write down the outcomes of all tests to show the system meets requirements.
  • Review and approve: Have a qualified team review and sign off on the validation documents.

Your system must consistently produce accurate and reliable results, document any changes, and be secure to prevent unauthorised access or alterations.

Audit trails

Audit trails are essential for tracking changes to electronic records. They record who made changes, what changes were made, when, and why.

To manage audit trails properly:

  • Secure logs to prevent tampering.
  • Record details like date, time, user ID, and nature of each change.
  • Review audit trails regularly to ensure compliance.
  • Restrict access to authorised personnel only.

Copies of records

Ensuring your electronic records are accessible and complete is key. Records must be available for review by regulatory authorities, and they should be complete, accurate, and in a readable format.

To maintain record copies:

  • Store records in easily retrievable formats.
  • Regularly back up records to prevent data loss.
  • Implement access policies to ensure only authorised personnel can access records.
  • Verify that records can be quickly retrieved when needed, especially during an audit.

Record Retention

Properly storing records for the required period is crucial for compliance. Records must be stored in a way that protects their integrity and makes them available for the entire retention period required by regulations.

To ensure proper record retention:

  • Follow a retention schedule for how long records need to be kept.
  • Use secure, controlled environments for storing records.
  • Check stored records periodically to ensure they remain intact and accessible.
  • Implement policies for the secure disposal of records once their retention period expires.

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FDA 21 CFR Part 11 Compliance Checklist
FDA 21 CFR Part 11 Compliance Checklist

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