Gamp 5 Categories With Examples

Software for a simple pH meter or a digital scale.

GAMP 5 Software Categorization: A Risk-Based Framework for System Validation gamp 5 categories with examples

Focus on User Requirements Specifications (URS) and "Black Box" testing to ensure the software does what you need it to do in your specific environment. Examples: Software for a simple pH meter or a digital scale

Custom PLC (Programmable Logic Controller) code for a unique assembly line robot. Summary Table: Effort vs. Category Risk Level Primary Validation Focus Cat 1 Infrastructure Installation Qualification (IQ) Cat 3 Non-Configured Low/Medium URS & Operational Testing Cat 4 Configured Medium/High Configuration Specs & Risk Assessment Cat 5 Code Review, Design Specs, Full Testing Why Categorization Matters Summary Table: Effort vs

These are "off-the-shelf" (OTS) software packages that are used exactly as they are provided by the vendor. You might enter data into them, but you aren't changing how the software itself functions.

You must document the configuration (Configuration Specification) and test that the specific configurations work as intended. Vendor audits become more important here. Examples: