Part 11 scope guidance and its 5 linked instruments

FDA guidance on how it applies Part 11. FDA says it will not enforce certain requirements on validation, audit trails, record retention and record copying, and sets criteria for legacy systems. Part 11 remains in effect, and predicate rule requirements still apply.

The US regulation setting the conditions under which FDA treats electronic records and signatures as equivalent to paper records and handwritten signatures: validation, audit trails, access controls, record protection and signature controls.

FDA's question-and-answer guidance on data integrity in drug manufacturing: ALCOA, audit trail review, access controls, shared logins and when electronic data are CGMP records.

FDA recommendations for sponsors, clinical investigators, review boards and contract research organisations on using electronic systems, records and signatures in clinical investigations, and when FDA treats them as equivalent to paper records and handwritten signatures.

FDA's risk-based approach to assuring software used in production and quality systems, favouring critical thinking and unscripted testing where risk is lower. Final since September 2025 and updated in February 2026 to align with the QMSR.

FDA guidance setting out the validation principles it considers applicable to medical device software, and to software used to design, develop or manufacture medical devices.

• 5 Sep 2003 Final guidance issued

• ~1 Mar 1997 Final rule issued (March 1997)
• 20 Aug 1997 Effective

• ~1 Dec 2018 Final guidance published (Dec 2018)

• 1 Oct 2024 Final guidance issued (October 2024)

• 13 Sep 2022 Draft guidance published
• 24 Sep 2025 Final guidance published
• 3 Feb 2026 Updated and retitled for QMS software

• 9 Jun 1997 Draft version 1.1 dated 9 Jun 1997
• 11 Jan 2002 Version 2.0 issued, superseding the 1997 draft