Gamp Classification [extra Quality] -

❌ – 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.

✅ – Category 4 & 5 explicitly require supplier assessment, pushing companies to audit vendors – a critical but often overlooked step. gamp classification

✅ – Regulators (FDA, EMA) and auditors recognize GAMP categories. They provide a clear starting point for any validation plan. ❌ – Treats all configured software (Cat 4)

❌ – 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

⭐⭐⭐⭐ (4/5) — Critical for compliance, yet showing its age in parts. 1. What is GAMP Classification? The GAMP (Good Automated Manufacturing Practice) 5 categorization system (from ISPE) classifies computerized system components into Software Categories (1-5) and Hardware Categories (1-2) . The goal: determine the level of validation rigor based on risk and complexity.