US FDA Title 21 CFR Part 11 Pocket Guide
- Electronic Records; Electronic Signatures
- Scope and Application - August 2003
This regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records.
This part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.
Also includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.