FDA 21 CFR Part 11 Electronic Records and Signatures

Requirements for trustworthy electronic records, electronic signatures, audit trails and system validation.

Jurisdiction: US
Issuer: FDA
Effective: 1997-08-20

Sectors

Healthcare & Pharma Food & Agriculture IT & Cybersecurity Manufacturing

Articles (10)

§ 11.1 Scope.§ 11.2 Implementation.§ 11.3 Definitions.§ 11.10 Controls for closed systems.§ 11.30 Controls for open systems.§ 11.50 Signature manifestations.§ 11.70 Signature/record linking.§ 11.100 General requirements.§ 11.200 Electronic signature components and controls.§ 11.300 Controls for identification codes/passwords.