21 CFR Part 11

Title 21 of the Code of Federal Regulations (CFR) is reserved for rules of the United States Food and Drug Administration (FDA). 21 CFR Part 11 is that part entitled “Electronic Records; Electronic Signatures.” It addresses the following subjects as they pertain to electronic records and electronic signatures: Archiving, Audit Trails, Electronic Copies for FDA, Glossary, Time Stamps, and Validation.