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GAMP 5 Categories and Validation Guide by EngFaisal Alrai is a document available to read on EtoBox.

What is GAMP 5 Categories and Validation Guide about?

The document discusses GAMP categories and associated validation deliverables. It describes the four GAMP5 categories - Category 1 includes infrastructure software, Category 3 includes non-configurable software like COTS, Category 4 includes configured software like LIMS, and Category 5 includes bespoke software. It lists the validation deliverables required for each category, with more deliverables needed for higher categories involving more customization. Category 1 requires the fewest deliverables and Ca

Author

EngFaisal Alrai

Language

EN