FDA 21 CFR Part 11
Electronic Records, Electronic Signatures (US)
US FDA requirements for electronic records and signatures: closed-system audit trail, unique user ID, authority checks, time-stamped records.
Official sourceRegulations
Regulations cited in chromatography QC
A quick reference. Links go to the official regulator's text — not to our paraphrase.
EU GMP Annex 11
Computerised Systems (EU)
European GMP requirements for computerized systems used in regulated activities. Validation lifecycle, audit trail, data integrity.
Official source WHO TRS 1033 Annex 4
Data integrity guidelines
WHO Technical Report Series 1033 Annex 4 — definitive expression of ALCOA+ data integrity principles.
Official source NMPA «Drug Records and Data Management» (2024)
China NMPA pharmaceutical record requirements
Chinese pharmaceutical regulator requirements: truthful, accurate, complete, traceable. Manual transcription requires two-person review.
Official source ICH Q9 (R1)
Quality Risk Management
Risk-based approach to quality. Useful framing for validating any new tool in a QC workflow.
21 CFR Part 211
Current Good Manufacturing Practice for Finished Pharmaceuticals
US GMP — covers laboratory controls (Subpart I) and records (Subpart J).
Official source