✅ – Regulators (FDA, EMA) and auditors recognize GAMP categories. They provide a clear starting point for any validation plan.
✅ – Category 4 & 5 explicitly require supplier assessment, pushing companies to audit vendors – a critical but often overlooked step.
✅ – Distinguishes COTS servers (low risk) from custom control panels (high risk) – helpful for OT (Operational Technology) systems. 3. Weaknesses & Gaps (Where it struggles) ❌ Digital & Cloud Blindness – Originally written for on-premise, waterfall projects. Doesn’t clearly handle SaaS (is it Cat 3 or 4?), microservices , or containerization (Docker/K8s). Many interpret SaaS as Cat 4, but the fit is awkward.