Document management software 21 cfr part 11
Guidance for a 21 CFR Part 11 implementation on document management, The details of the MOM management pack for all relevant software are available in the
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Draft Guidance for Industry Guidance for Industry 21 CFR Part 11; Electronic with the exception of part 11, are referred to in this document as predicate rules.
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CFR – Code of Federal Regulations Title 21. PART 11: ELECTRONIC RECORDS The requirements of this part are met; and (2) The document or parts of a document to
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