How is Agile PLM Compliant with FDA Part 11.200(a)(3)
(Doc ID 2580506.1)
Last updated on AUGUST 23, 2019
Applies to:Oracle Agile PLM Framework - Version 188.8.131.52 and later
Information in this document applies to any platform.
How is Agile PLM compliant with FDA Part 11.200(a)(3)?
FDA Part 11.200(a)(3) is stated as below:
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.
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