GAMP 5 provides a risk-based approach to validating computer systems in GxP environments.
Main categories
Software is categorized by degree of customization — from infrastructure and commercial off-the-shelf (COTS) products to configured and bespoke systems. The more customization, the larger the validation effort.
Practical meaning
Categorization drives the required document set (DQ/IQ/OQ/PQ) and the depth of testing. A risk-based mindset focuses resources where risk is highest.