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

Subpart A, General Provisions, define what electronic records and electronic signatures must comply with this regulation. The records subject to Part 11 are those in electronic form "created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations." 1 The regulation also applies to any electronic records submitted to the FDA even if the record is not specifically identified in the FDA regulations. Any signatures applied electronically to such records must also comply with the Part 11 regulations.

The General Provisions also definitively state that electronic records and electronic signatures in compliance with this regulation will be considered the equivalent of paper records and handwritten signatures applied to paper.