21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA)
Part 11 applies to all FDA-regulated industries, including pharmaceuticals, biotech, medical devices, and food and beverage manufacturers.
It defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records and handwritten signatures.
The regulation applies to records in electronic format that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations.
The regulation outlines specific requirements for electronic records and electronic signatures, including access controls, audit trails, and system validation.
Part 11 compliance requires organizations to implement controls and procedures to ensure that electronic records and electronic signatures are accurate, secure, and reliable.
The two components of an electronic signature are a unique identifier for the signer and a means of verifying the signature's integrity, such as a digital signature or secure authentication method
Electronic signatures must be unique to the individual signing and must be protected from unauthorized use.
21 CFR Part 11 requires that electronic records and signatures be protected by appropriate security measures, such as access controls and encryption.
The FDA may take enforcement action against organizations that do not comply with 21 CFR Part 11, including issuing warning letters, fines, or even criminal charges
Complying with 21 CFR Part 11 requires implementing controls and procedures to ensure accuracy, reliability, and security of electronic records and signatures.