GAMP 5 - Good Automated Manufacturing Practice GAMP5-Crosswalk-ICH-FDA-EMA-MHRA: Crosswalk to ICH Q9/Q10, FDA Part 11, EU Annex 11, MHRA Data Integrity and Sectoral Standards

GAMP 5 coordination with adjacent regulatory + standard frameworks. ICH Q9 QUALITY RISK MANAGEMENT: foundational risk-based decision making applicable to computerised systems validation; GAMP 5 implements ICH Q9 in CSV context. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM: integrates GAMP 5 CSV into the broader pharmaceutical quality system including management responsibility + product realisation + continual improvement. FDA 21 CFR PART 11 - separately tracked in corpus as FDA 21 CFR Part 11 (verified); the partnership: GAMP 5 provides the lifecycle approach + Part 11 provides the electronic-records + electronic-signature specifics; CSA (Computer Software Assurance) 2022 Draft refines critical-thinking application. EU ANNEX 11 (Computerised Systems): EU equivalent to Part 11 + integrates with GMP context. MHRA DATA INTEGRITY GUIDANCE (2018 + updates): UK regulator data integrity expectations + ALCOA+ + life-cycle data governance + applies to computerised systems. WHO TRS GUIDELINES (Technical Report Series): WHO GxP guidelines including computerised systems. PIC/S PI 011 + PI 041: Pharmaceutical Inspection Cooperation Scheme good practices including computerised systems + data integrity. ISO 13485 + IEC 62304 (medical devices): for medical device software + integrated with GAMP 5 for hybrid pharma + medical device organizations. ISO/IEC 27001 + ISO/IEC 27017 + ISO/IEC 27018 + cloud-relevant standards. NIST + CSF + 800-53 for IT general controls supporting GAMP 5.