how to caary out software validation of plc & qms software?
As per GAM-5 guideline
Refer GAMP 5 guideline,it has all the detail including categorization of the software and upto what extent need to qualify the software.
Software validation starts from URS. Once URS is done, IRA (initial risk assessment) to be prepared that determines the Category of Software as per GAMP5, applicability of ER-ES, vendor assessment and GxP applicability. Once category is identified, further documents like Functional requirement specification, design specification, configuration specification are either prepared or arranged by vendor. Validation plan and functional risk assessment are prepared. Once all these documents are available, IQ, OQ and PQ documents are prepared and executed. Prior of Executing PQ, SOP of that particular should be effective. After successful completion of PQ, requirement traceability matrix is prepared against the URS where individual requirement whether available in software functionality is available or not is verified. If all URS are complete, Release note is prepared and approved. After approval the system is released for routine use.
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It is better to perform, RTM (Requirement traceability matrix) at each stage, so it gives better tracking and if anything is missing. we can identified the gap.
so, we can minimize the rework of SOP preparation and effectiveness and further qualification activity.
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