This is really a practical approach problem
I have few questions regarding this sofware validation issues. Our organization is very big having oracle ERP software with 10 different sites and connecting by the different leased lines.
At present validation is going as per the GAMP4 concept,
As per GAMP5, Risk based approach is required to fulfill regulatory requirements.
But at present i am in confusion,
I have completed retrospective validation up to OQ level. Now we have to be carry out the PQ for the same software(Orcle ERP).
Out put of the reports like Approved supplier list report, MRR, Quarantine reports, PO, approved and rejected label reports etc., are different to the different sites.
Shall PQ to be performed for all the sites from the copied live instance (Validation instance)? or only these reports shall be tested and verified in the live(Production) isnstance.
Whether the tests performed in the OQ shall be repeated in the PQ at all the sites?
Traceability matrix is only saying that GxP related reuirement must be tested in either OQ or PQ.
If it is tested in OQ, then i think that it is not required to test again in the PQ for consistancy.
For consistancy of the Transactions out put, is it 3 trails shall be carried out in the PQ or one tail is required for PQ to prove the transaction consistancy.
Actually what is to be tested in the PQ, whether URS verification or Consistancy?
Pl let me know the clarifications regarding the above few qestions.
I shall be very thankful if you can clarify the same.
We Want know the another requirement,
Any nice software is available for Quality Module to cover QC and QA activities including stability studies. that is to be inteface with oracle ERP software
Pl suggest me.
Thanking You
Tarakesh