21 CFR Part 11

21 CFR Part 11 is a regulation from the U.S. Food and Drug Administration that sets standards for electronic records and electronic signatures in the pharmaceutical, biotech, and related industries. It ensures that digital data is trustworthy, secure, and comparable to paper records. The rules establish requirements for data integrity, user authentication, audit trails, and secure access, helping organizations maintain the accuracy and reliability of electronic information used in regulatory and quality processes. Essentially, it provides a framework to ensure digital records are legally equivalent to traditional paper documentation.