Title 21 CFR Part 11 is the part of Title 21 code of Federal Regulations that establish the Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).

Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations.

Attend our free, live 45-minute webinar to learn about how FDA CFR Part 11 compliance can be achieved by following the best practices developed by our speaker and the tools that will help you achieve continuous compliance.