Here is a deep dive into the four active GAMP 5 software categories and how to apply them. Why Categorize Software?
Not all software is created equal. Validating a simple spreadsheet requires a different level of rigor than validating a global Enterprise Resource Planning (ERP) system. Categorization allows you to: gamp 5 software categories
By correctly identifying the category early in the project, you eliminate unnecessary documentation, reduce testing time, and focus your energy on the areas that actually pose a risk to product quality and patient safety. Here is a deep dive into the four
If yes, is it used "as-is" (Cat 3) or "configured" (Cat 4)? you eliminate unnecessary documentation
