The current guidelines recognize four active software categories. Category 2 was a legacy classification from older iterations (covering firmware) and remains completely obsolete. GAMP Category Classification Type Inherent Risk Profile Validation Strategy Category 1 Infrastructure Software & Lifecycle Tools
In your or User Requirements Specification (URS) , you must include a statement such as: gamp software categories
When documenting your validation plan, follow this decision tree: gamp software categories
This paper answers three key questions:
This refers to commercial off-the-shelf (COTS) software that is used "out of the box." The user cannot change the software code or the business processes/logic within the software. It is what it is. gamp software categories