We are implementing and validating a CDMS. Have a clarification on the Performance Qualification to be performed to execute a ‘good’ CSV. We have been provided a “full functionality” test script by the CDMS vendor that checks every possible functionality of the CDMS. We plan to run this full functionality test script on our TEST INSTANCE of CDMS. Do we need to execute the full functionality on PRODUCTION INSTANCE TOO??
Also for every new protocol/study we plan to pick a sub set of the full functionality test script and execute as PQ. Does this study specific PQ need to be executed on TEST AND PRODUCTION INSTANCE? If this is executed on PRODUCTION we would need to provide a dummy name for the same to ensure it does not conflict with the actual study.
Can some one help??