Gamp 5 Hardware Categories [hot]

| 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 |

The more configurable and complex the hardware, the higher the risk of undetected failure, and thus, the more rigorous the life cycle activities. gamp 5 hardware categories

A critical, yet often misunderstood, component of GAMP 5 is the . | Category | Description | Typical Examples |

Under GAMP 5 guidelines, hardware is divided into two primary categories based on its complexity and provenance. Description Key Deliverables Standard Description Key Deliverables Standard This is the most

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.

GAMP 5 categorizes hardware into Standard (Category 1) and Custom (Category 2) components, with validation efforts scaled according to complexity and proven reliability. Standard components require basic installation verification, while custom hardware demands rigorous design documentation, installation qualification, and operational qualification.

These are hardware items designed and built specifically for a particular application. They often contain custom firmware or unique electronic configurations that are not available as standard products.