V-Model Lifecycle - specification phases mirrored by verification phases. SPECIFICATION SIDE: (a) USER REQUIREMENTS SPECIFICATION (URS) - what the business needs the system to do + GxP requirements + regulatory + audit + user-defined functional + non-functional; (b) FUNCTIONAL SPECIFICATION (FS) - what the system does to meet URS; (c) DESIGN SPECIFICATION (DS) - how the system is designed + architecture + data flows + interfaces. VERIFICATION SIDE: (a) INSTALLATION QUALIFICATION (IQ) - verifies system installed per design; (b) OPERATIONAL QUALIFICATION (OQ) - verifies system operates per functional specification under simulated operating conditions; (c) PERFORMANCE QUALIFICATION (PQ) - verifies system performs per URS under actual operating conditions including throughput + reliability + business processes; (d) USER ACCEPTANCE TESTING (UAT) overlapping PQ. TRACEABILITY MATRIX: links URS requirements to FS/DS + test cases + test results + ensures coverage + supports inspection + change-impact analysis. RISK-PROPORTIONATE: high-risk requirements receive more verification depth + redundancy + independent verification; low-risk requirements may receive lighter touch + sampling. RE-USE: across similar systems + leverage prior validation knowledge.
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