Why? Because the way you validate a commercial off-the-shelf printer driver should be different from how you validate custom sterilization control software.

Let’s break down the four categories of GAMP 5 software. Examples: Windows OS, Linux, database engines (SQL), antivirus software, network monitoring tools.

This is the "sweet spot" for most pharma companies. Category 4 software is complex, off-the-shelf software that is to your specific business process.

This is the foundation. Category 1 software is the underlying operating system or basic infrastructure that your GxP applications run on top of.

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.

Category 5 carries the highest risk because there is no operational history. You are the developer, so you are responsible for every bug.