This is the foundation. Category 1 software is the underlying operating system or basic infrastructure that your GxP applications run on top of.
If you work in pharmaceutical, biotech, or medical device manufacturing, you’ve likely heard the phrase “GAMP 5” thrown around in validation meetings. But what does it actually mean for the software on your desk or the code running your production line? gamp 5 categories of software
You are not writing custom code. You are using the software’s built-in tools to turn features on/off, create workflows, set user permissions, and design reports. This is the foundation