Which item is NOT typically required by 21 CFR Part 11 for electronic records?

• A. System validation
• B. Audit trails
• C. Electronic signatures
• D. Physical paper backup stored off-site

Answer: (D)

Part 11 focuses on making electronic records trustworthy and verifiable. To meet these requirements, the system used to create or store electronic records must be validated to show it operates correctly and consistently. An audit trail is required to capture who did what and when, so the history of data changes is traceable. Electronic signatures are needed to provide authentication and to bind the signer to the record. A physical paper backup stored off-site is not a standard Part 11 requirement; the regulation does not mandate off-site paper backups for electronic records, though backups for continuity may be used under broader quality and security controls.