How is Agile PLM Compliant with FDA Part 11.200(a)(3)
(Doc ID 2580506.1)
Last updated on FEBRUARY 07, 2021
Applies to:Oracle Agile PLM Framework - Version 18.104.22.168 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.
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document