RE: RE: sop of change control Contribution from JD Mallet written on 7/16/2008 at 09:41
Original contribution: RE: sop of change control written by Rahul on 7/16/2008 at 07:59) This is one possible categorization. The principle is to analyze the characteritics of a planned change and to use this knowledge to assess the expected impact of the change. But to my understanding it is not mandatory that the classification has to be done by QA. If there is a clear procedure this can be done by other managers provided they properly document the case (sometimes it is very technical and a QA manager is not always an engineer or a graduated microbiologist). Answers to this contribution:
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