Implementing software applications compliant with 21 CFR 11
In: Pharmaceutical technology, Jg. 24 (2000), Heft 3, S. 118-132
academicJournal
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Zugriff:
FDA has issued a series of guidelines for electronic signatures and records management, beginning with 21 CFR 11, Electronic Records, Electronic Signatures, Final Rule (March 1997). These guidelines, rulings, and directives describe the agency's intent and high-level requirements. This article presents the medium-level requirements that affect software application developers and software maintenance personnel.
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Implementing software applications compliant with 21 CFR 11
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Autor/in / Beteiligte Person: | LOPEZ, O |
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Zeitschrift: | Pharmaceutical technology, Jg. 24 (2000), Heft 3, S. 118-132 |
Veröffentlichung: | Duluth, MN: Advanstar Communications, 2000 |
Medientyp: | academicJournal |
Umfang: | print, 4 ref |
ISSN: | 0147-8087 (print) |
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