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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 9.3.6.0 and later
Information in this document applies to any platform.

Goal

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.

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

Solution

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In this Document
Goal
Solution
References


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