❌ – GAMP assumes defined requirements before coding. Modern DevOps (CI/CD, weekly releases) struggles with the documentation-heavy IQ/OQ/PQ model. GAMP 5 Second Edition (2022) adds a supplement on agile, but it’s not yet mainstream.
✅ – Regulators (FDA, EMA) and auditors recognize GAMP categories. They provide a clear starting point for any validation plan. gamp classification
❌ – 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. ❌ – GAMP assumes defined requirements before coding
Overall Verdict: Essential foundation for risk-based validation, but requires modern interpretation for cloud, AI, and agile methods. ✅ – Regulators (FDA, EMA) and auditors recognize
❌ – Self-learning algorithms break the “configured vs. custom” boundary. A model that retrains post-deployment doesn’t fit Categories 3–5 cleanly.