Computer System Validation (CSV)


Validation is the process of qualifying the ERP software is functioning as per the guideline of WHO GMP  and does not allow the deviation so as the quality does not suffer. Once the software is validated, there after managing the system becomes easy. All the deviations must be noted and proper SOP’s followed in terms of running the system. Change control documents need to be written in the event of change of system. Progen qualifies all the validation process as per the requirement of Indian FDA, UKMHRA and USFDA.

Process to be followed while doing Validation

• Taking decision if the software is cGMP critical
• If yes then Making a MVP (Master Validation Plan)
• Making a core team for Validation
• Doing a complete validation according to GAMP and 21 CFR Part 11
• Doing IQ/OQ/PQ
• Making SOP(Standard Operating Procedure)