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Agile PLM は FDA Part 11.200(a)(3)にどのように準拠していますか (Doc ID 2580512.1)

Last updated on SEPTEMBER 10, 2019

適用範囲:

Oracle Agile PLM Framework - バージョン 9.3.0.0 以降
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目的

Agile PLM は FDA Part 11.200(a)(3)にどのように準拠していますか?

FDA Part 11.200(a)(3) は次のように記述されています:

Sec. 11.200 Electronic signature components and controls.
 (a) Electronic signatures that are not based upon biometrics shall:
  (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner
  requires collaboration of two or more individuals.

Ref: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=11.200
 

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