GAMP5

Category 3 1. Off the shelf – Not 1. User requirement Testing to include

configurable for a specification 1. Correct
specific business 2. Non-Configured product installation
processes 3. Requirement testing 2. Intended use
2. Risk assessment to met.
justify
Category 4 Configuration of 1. User requirement Testing to include
commercially available specification 1. Correct
software on a standard 2. Functional specification installation
hardware 3. Configuration 2. Configuration
specification of the system
4. Configured product 3. Functionality
5. Config testing that meets
6. Functional testing the business
7. Requirement testing process
4. Intended use
met
Category 5 No commercial Above one with design and
available software. module specification and
In-house developed testing.