Gamp Category 4 -

| Pitfall | Why it’s risky | Solution | | :--- | :--- | :--- | | | More configuration = more points of failure. | Apply the "Keep it as simple as possible" rule. | | Treating Cat 4 like Cat 3 | Skipping OQ for configurable features leads to undetected errors. | Test every configured rule/workflow. | | Testing vendor features you don’t use | Wastes time and resources. | In the URS and test plans, scope only your configured usage. | | Poor change management | Changing one config setting can break another. | Revalidate (or assess impact of) any configuration change. |

: Industrial control systems configured with predefined control routines. gamp category 4

refers to Configurable Software . These are software products that are not used "out of the box." Instead, they are configured by the user or system integrator to meet specific business processes. | Pitfall | Why it’s risky | Solution