Gamp 5 Software Categories

If yes, is it used "as-is" (Cat 3) or "configured" (Cat 4)?

This is the "sweet spot" for efficiency. Because the code is standard and widely used, the vendor’s quality system provides the assurance. The user simply needs to verify that the software works in their specific environment (PQ - Performance Qualification). You typically do not need to write functional specifications. gamp 5 software categories

GAMP 5 (Good Automated Manufacturing Practice, version 5) categorizes software based on its complexity and intended use to determine the appropriate level of validation. Software Category Overview If yes, is it used "as-is" (Cat 3) or "configured" (Cat 4)