Part 11 — Electronic Records; Electronic Signatures
Current through Sep 8, 2026
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.
Sections
- § 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.