What are GAMP 5 Software Categories?

What are GAMP 5 software categories?

There are 5 software categories as per the International Society for Pharmaceutical Engineering (ISPE).  In GAMP 4 there were 5 software categories but in GAMP 5 it was revised from 5 categories to 4 categories and mentioned as below:

  1. Category 1: Infrastructure Software including Operating System, Database managers.
  2. Category 3: Non-configurable Software including Commercial of the shelf software (COTS), Laboratory Instrument / Software.
  3. Category 4: Configured Software i.e. LIMS, SCADA, CDS, DCS.
  4. Category 5: Bespoke Software

Category 2 has been removed from GAMP 4 version. The Category is related to Firmware.

The GAMP software categories are introduced to provide an initial assessment of validation requirements or deliverables.

GAMP 5: It is a Risk-Based Approach to Compliant GxP Computerized Systems sets out guidelines for the risk-based evaluation of computer system accuracy, which is different for each system based on whether it is intended for use or not.


Also Read:

Equipment Qualification Principles and Practices

10 Method validation parameters

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