Part 11 Electronic Records; Electronic Signatures

Subpart A - General Provisions

• § 11.1   Scope
• § 11.2   Implementation
• § 11.3   Definitions

Subpart B - Electronic Records

• § 11.10   Controls for closed systems
• § 11.30   Controls for open systems
• § 11.50   Signature manifestations
• § 11.70   Signature/record linking

Subpart C - Electronic Signatures

• § 11.100   General requirements
• § 11.200   Electronic signature components and controls
• § 11.300   Controls for identification codes/passwords