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nonconforming materials report

Why my Electronic “Document Control System” may only be a “Document Management System” 

This paper will look at what may be missing in most of the electronic “Document Control Systems” on the market and the document control related observations identified in a recent FDA 483. A recent form 483 issued by the FDA sheds light on what the agency considers a document control system versus a document system. In the 483, the FDA cited the company for “Issuance and use of documents is not controlled.” The company had implemented an electronic document control system, or at least they thought they did…


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