GAMP 5 DATA INTEGRITY + 21 CFR PART 11 + EU ANNEX 11 alignment. ALCOA+ PRINCIPLES (FDA + EMA + MHRA Data Integrity Guidance): ATTRIBUTABLE + LEGIBLE + CONTEMPORANEOUS + ORIGINAL + ACCURATE + COMPLETE + CONSISTENT + ENDURING + AVAILABLE. DATA INTEGRITY BY DESIGN: build controls into system design - audit trails + secure time + access controls + integrity checks + transcription error prevention + change management; rather than bolt-on. 21 CFR PART 11 (FDA Electronic Records + Electronic Signatures) - separately tracked in corpus as FDA 21 CFR Part 11 (verified) - mandates: secure audit trails + electronic signature uniqueness + binding + non-repudiation + system access controls + record retention + validation of electronic systems + records-required-to-be-maintained vs records-submitted-to-FDA. EU ANNEX 11 (Computerised Systems): mirrors Part 11 with European specifics + applies to EU GMP-regulated activities; 17 requirements + risk-based + supplier management + accuracy checks + audit trails + electronic signatures + change + configuration management. INTEGRATION: GAMP 5 + Part 11 + Annex 11 + ICH Q10 PQS + ISPE Records and Data Integrity Guide (RDIG) form the integrated framework for pharma computerised systems data integrity. 2024-2025 EMA + FDA enforcement focus: data integrity in cloud + AI/ML training data + audit-trail completeness + remote inspection findings.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.