Gamp 5 Categories Of Software [ Secure ]
Low (provided you use standard, commercially available versions). Category 3: Non-Configured Products Note: GAMP 5 originally included Category 2 (Firmware), but the latest GAMP 5 guide (Second Edition) has merged legacy Category 2 into Categories 1 and 3. We'll focus on the active categories.
Why? Because the way you validate a commercial off-the-shelf printer driver should be different from how you validate custom sterilization control software. gamp 5 categories of software
This is the foundation. Category 1 software is the underlying operating system or basic infrastructure that your GxP applications run on top of. Low (provided you use standard