What does 21 CFR - Part 11 regulate?

The regulation known as 21 CFR Part 11 specifically addresses the use of electronic records and electronic signatures in FDA-regulated environments. This part of the Code of Federal Regulations sets forth criteria under which electronic records and signatures are considered to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. The purpose of these regulations is to ensure that electronic systems used in clinical trials and other FDA-regulated activities maintain data integrity, security, and accountability.

Part 11 establishes standards for the validation of electronic systems, ensuring that they function as intended and produce accurate results. It also mandates controls around access to electronic records and the integrity of electronic signatures. This includes the necessity for systems to have audit trails, user access controls, and proper training for personnel involved in these processes. By doing so, 21 CFR Part 11 aims to foster confidence in electronic records and signatures, allowing for a more efficient regulatory process while still upholding necessary compliance and quality standards in clinical trials and other pharmaceutical activities.