Gamp Category 4 ⚡

Category 4 refers to commercial off-the-shelf (COTS) software that is tailored to meet specific business processes through configuration without changing the underlying source code. Unlike simple Category 3 tools used "as-is," Category 4 systems allow users to modify workflows, data logic, and calculations using vendor-supplied tools. Category 3 (Non-Configured) Category 4 (Configured) Category 5 (Custom) Custom-written Modification None (Run-time only) Configuration of modules Scripting/Coding Validation Effort Moderate to High Examples Microsoft Word, simple instruments LIMS, ERP, SCADA Bespoke apps, VBA macros Why Category 4 is "The Middle Ground"

| Test Type | What it verifies | Performed By | | :--- | :--- | :--- | | (Installation Qualification) | Software installed correctly on correct hardware/OS. | User / IT | | OQ (Operational Qualification) | Configured functions work as intended (e.g., user roles, workflows, alerts). | User / QA | | PQ (Performance Qualification) | The system performs the real-world business process (end-to-end with trained users). | User / QA | gamp category 4

When in doubt, remember: If you can change how it behaves without writing code, it’s Category 4—and you must validate those changes. | User / IT | | OQ (Operational