GAMP 5 RISK-BASED + LIFE-CYCLE + LEVERAGE-SUPPLIER + SCALABLE + CRITICAL-THINKING approach. KEY CONCEPT 1 RISK-BASED: validation effort proportional to risk to product quality + patient safety + data integrity + regulatory impact; risk assessment per ICH Q9 + ISO 31000 + at system level + business process level + functional level + leverages prior knowledge. KEY CONCEPT 2 LIFE-CYCLE: V-Model lifecycle integrating SPECIFICATION (URS + FS + DS) with VERIFICATION (IQ + OQ + PQ); reuse across system lifecycle; from concept to retirement. KEY CONCEPT 3 LEVERAGE SUPPLIER INVOLVEMENT: qualified supplier provides documentation + testing + tooling + reduce duplication; supplier audit + assessment program; supplier-provided documentation accepted when leverage is justified. KEY CONCEPT 4 SCALABILITY: approach tailored to system complexity + risk + business criticality; small instruments to enterprise systems; not one-size-fits-all. KEY CONCEPT 5 CRITICAL THINKING (NEW EMPHASIS IN 2ND EDITION 2022): apply judgment over checkbox compliance; consider system context + actual risk + business need + regulatory expectations; document rationale; avoid over-validation + under-validation. INTEGRATION: with FDA Computer Software Assurance (CSA) 2022 Draft Guidance which emphasises critical thinking + assurance through assessment + risk-based testing + automation.
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