would fall under GAMP Category 3 for while it is has parameters entered under the configuration it does not define functionality or a process flow. In a process control system a DCS would be configured from standard modules to control a specific process and would fall under GAMP Category 4.Īn electronic chart recorder which is also configured with Input Ranges, Alarm Setpoints, etc.
#Categories of softwares software
GAMP Category 3 – Non Configurable SoftwareĬonfiguration relates to adding functionality through standard modules, library items to standard software applications to meet the business requirements. The validation is performed on the hosted application not on the infrastructure. Infrastructure is qualified but not validated. Note: Infrastructure should be built, configured and deployed in accordance with defined process / procedure and critical aspects and / or configuration verified.
Infrastructure software in its most simple form is the operating system which the application software resides.Īdditional software for managing the infrastructure the process control system includes:
Unless a very simple control system (PLC and HMI) there is likely to be some elements of infrastructure software. GAMP Software Category 1 – Infrastructure Software
The categories detailed within this post are based on GAMP 5 Software Categories. In this post we are looking at types of software which fall in to these categories for Process Control Systems / Automation Systems.Ĭategorising software is used to support the approach to the validation based on complexity and novelty of the computerised system. In the article Validation Determination the use of categorising software was discussed and how this can support the approach to the validation.
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