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technical and procedural controls that guarantee that every one actions that create, modify or delete Digital info might be recorded in impartial, Laptop or computer-produced audit trails or other metadata or alternate documents that record the “what” (e.Periodic preventive servicing things to do shall be finished for devices less than Team C (
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(file) Treatments shall be published describing in enough depth the Manage processes employed for that issuance of labeling; this kind of prepared methods shall be followed.identifies recommendations that, when followed, will make sure compliance with CGMPs. An alternate method could possibly be utilized if such strategy satisfies the requirements
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