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21 CFR Part 11: Validation - Food and Drug Administration

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Draft Guidance for Industry - Not For ImplementationKarl E. Wiegers, Creating a Software Engineering Culture, Dorset House Publishing, 1996.ISBN 0-932633-33-1.Karl E. Wiegers, Software Inspection, Improving Quality with Software Inspections,Software Development, April 1995, pages 55-64.Karl E. Wiegers, Software Requirements, Microsoft Press, 1999. ISBN 0-7356-0631-5.DocID <strong>Validation</strong>Draft_PostRES.doc08/29/01<strong>21</strong>

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