Gamp Category 4 [top]

| Feature | Cat 3 (Non-Config) | | Cat 5 (Custom) | | :--- | :--- | :--- | :--- | | Code modified by user? | No | No | Yes | | User sets parameters? | No | Yes | N/A | | Validation effort | Low | Medium | High | | Testing focus | Basic I/O | Configuration testing | Code & logic testing | | Vendor dependency | High | Medium | Low |

GAMP Category 4: A Guide to Configured Software Validation In the highly regulated world of pharmaceuticals and medical devices, provides the definitive framework for ensuring computerized systems are fit for their intended use. GAMP Category 4 , known as Configured Products , represents perhaps the most prevalent and complex software classification in modern manufacturing. What is GAMP Category 4? gamp category 4

Vendors typically provide the FS. Your job is to document the —the exact settings, parameters, and rules you will apply to the software. | Feature | Cat 3 (Non-Config) | |

Need to apply this to a specific system? Start with a GAMP 5-compliant risk assessment and a supplier audit. GAMP Category 4 , known as Configured Products