Archiving requirements for electronic pharmaceutical manufacturing documents and associated executable software.
Many pharmaceutical manufacturers are currently evaluating the feasibility of electronic batch record (EBR) and electronic document management (EDM) systems. Considerable effort has been invested in the design of the batch record files and electronic signature devices and procedures. Much less consideration has been given to the potential need for pharmaceutical manufacturers to be able to re-create the operational software environment necessary to review archived documents at some future date. The paper discusses methods, policies, and equipment that can be used to fulfill this function.
Quinn
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Hollis Group, Incorporated, Paoli, Pennsylvania.
D001109:Archives; D003199:Computer Systems; D003625:Data Collection; D004345:Drug Industry / Q000458:organization & administration*; D005568:Forms and Records Control / Q000379:methods*; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration