GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11 - Electronic Records with Scope & Application

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1-933734-00-0

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.

















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