Creating a for a specific software category. Which of these would be most helpful for your project?
If it’s an operating system, it’s likely Category 1. gamp categories
Most enterprise systems fall into this category. These are standard products where the user can configure specific business processes or workflows without changing the software's source code. Creating a for a specific software category
: Focuses on verifying that the system meets user requirements and is installed correctly. A full "V-Model" validation is usually not necessary. Category 4: Configurable Software it’s Category 5. If you'd like
If you are just "turning on" features, it's Category 4. If you are writing code, it’s Category 5. If you'd like, I can help you with: Drafting a Validation Master Plan template. Comparing GAMP 4 vs. GAMP 5 changes in detail.