21 CFR Part 11, also known as Part 11, is a regulation issued by the U.S. Food and Drug Administration (FDA) that sets forth the requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries. The title of Part 11 is “Electronic Records; Electronic Signatures.”
The regulation was established to provide a framework for the use of electronic records and electronic signatures that is equivalent to the use of paper records and handwritten signatures in FDA-regulated industries. It was introduced to help streamline and modernize documentation practices in these industries while ensuring data integrity, security, and authenticity.
Key aspects of 21 CFR Part 11 include:
- Scope: Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any FDA regulation. This includes documents related to clinical trials, manufacturing, quality control, and more.
- Electronic Signatures: The regulation defines the criteria for electronic signatures, including methods to link the signature to the individual, ensure its security, and verify its authenticity.
- Audit Trails: Systems subject to Part 11 must have mechanisms for creating and maintaining secure and accurate audit trails that document any changes or deletions of electronic records.
- Validation: Electronic systems used to create, modify, or maintain electronic records must be validated to ensure they are reliable and compliant with Part 11 requirements.
- Security: Part 11 mandates that electronic records must be protected from unauthorized access, alteration, or destruction. It requires the implementation of security measures to safeguard data integrity and confidentiality.
- Documentation and Record Retention: The regulation specifies requirements for documenting electronic record systems, establishing retention periods, and ensuring records are readily available for inspection by the FDA.
Compliance with 21 CFR Part 11 is essential for organizations operating in FDA-regulated industries to maintain data integrity and ensure the safety and efficacy of their products. Failure to comply with Part 11 requirements can lead to regulatory actions and consequences, including product recalls, warning letters, and legal penalties. Therefore, companies in these industries invest significant resources in ensuring their electronic record-keeping systems and processes are in accordance with Part 11.