Category Of Software & Hardware As Per GAMP Guideline & their Validation

Updated: Mar 26

Category of software

Application are categorized into following software categories as per GAMP 5 guideline

1. Category 1 – Infrastructure Software:- There are two types of software in this category:

A. Commercially available layered software: - Software upon which applications are built or applications are developed to run under the control of this kind of software. E.g., Database managers, programming languages, Middleware, ladder logic interpreters etc.

B. Infrastructure software tools: This software not used directly for business purpose but supports/manages the computer hardware/ network Infrastructure. E.g., operating systems, network monitoring software, batch job scheduling tools, security software, anti-virus.

Typical Approach for validation:- Record version number, verify correct installation by following approved installation procedure.

2. Category 2 – This Category is no longer used in GAMP 5

Category 2 Firmware is no longer a separate category, since modern firmware can be so sophisticated that there is no longer any justification for differentiation. Firmware can fit into any of the categories depending on the nature of the embedded software.

3. Category 3 – Non-Configured Products (COTS As-Is)

This category includes off-the-shelf products used for business purposes. In this type of software no customization or configuration performed.

Systems that cannot be configured to conform to business processes and systems that are configurable but for which only the default configuration is used or only run time or environmental configurations are done. E.g., Firmware based applications, COTS software, and instruments software.

Supplier assessment may not be necessary, the need for, and extent of; supplier assessment should be based on risk.