Abstract
Information technology and quality assurance professionals in various Food and Drug Administration-regulated industries are seeking advice on how to maintain electronic records and associated computerized systems in compliance with 21 CFR 11. System and record maintenance activities have raised issues with respect to: Migrating electronic records to new systems, archiving electronic records, and reconstructing electronic records in the event of a fraud investigation. Professional societies and industry groups have continued to discuss these issues since 21 CFR 11 was released in its final form in March 1997. This article has been written to present a summarization of some of those discussions.
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