Overview of Part 11

The Part 11 regulation contains three major divisions: Subpart A - General Provisions, Subpart B - Electronic Records, and Subpart C - Electronic Signatures.

The outline of the regulation is as follows:

• 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 (Section 11.30 is outside the scope of this guide)

  • 11.50 Signature manifestation

  • 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