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How can I obtain software validation?

Question asked by vct70 on May 29, 2020
Latest reply on Jun 1, 2020 by ryoboyle

I have audit last month, an one audit finding was: "Per CGMP regulatory requirements, all computer systems must be validated / qualified to demonstrate they operate as intended at the user site" the auditor observe that I dont have IQ, OQ, PQ validation of  Agilent HPLC softwares OpenLAB CDS ChemStation Edition 01.07.255 (Rev.C.01.07-SR2) and  Agilent OpenLAB CDS ChemStation Edition 01.07.027 (Rev.C.01.07). I have only a certificate for local distributor.

 

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