While Software Categories often take the spotlight in GAMP 5, hardware categorization is an equally critical component for maintaining compliance in GxP-regulated industries like pharmaceuticals and biotechnology.
| Category | Description | Typical Examples | Risk | Documentation Need | | :--- | :--- | :--- | :--- | :--- | | | Standard, Non-Configurable | Printer, basic monitor, cable | Very Low | Inventory & Inspection | | 3 | Standard, Configurable | PLC, managed switch, HMI | Medium | Configuration Spec & IQ | | 4 | Custom/Bespoke Hardware | Custom PCB, unique controller | High | Full Design Spec & FAT/SAT | gamp 5 hardware categories
This is the most common category. These are off-the-shelf hardware items that have standard, user-configurable parameters (e.g., IP addresses, baud rates, I/O settings) but no custom firmware or programmable logic. While Software Categories often take the spotlight in
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