❌ – Treats all configured software (Cat 4) similarly, but a simple config (e.g., setting a date format) differs vastly from complex logic (e.g., 500 business rules in a LIMS). No sub-category for configuration complexity.
✅ – Regulators (FDA, EMA) and auditors recognize GAMP categories. They provide a clear starting point for any validation plan. gamp classification
✅ – 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. ❌ – Treats all configured software (Cat 4)