FDA data integrity Q&A and its 4 linked instruments

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.

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.

US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data.

The international guideline on quality risk management. It is the basis for scaling validation effort to risk in Annex 11, Annex 22 and computer software assurance, and the 2023 revision addresses subjectivity, formality and risk-based decision-making.

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.

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

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

• 29 Sep 1978 Published at 43 FR 45077

• 9 Nov 2005 Original Q9 reached Step 4
• 18 Nov 2021 Q9(R1) released for public consultation at Step 2
• 18 Jan 2023 Reached Step 4 (final)

• 5 Sep 2003 Final guidance issued