FDA 21 CFR Part 11 Compliance / E-Signatures for Change Control

FDA 21 CFR Part 11 Compliance / E-Signatures for Change Control

Does anyone have experience with implementing ServiceDesk Plus (specifically the Change module) for use with regulated GxP systems in a life sciences organization?

Part 11 outlines requirements for electronic records and electronic signatures.

I am currently looking for any information on 3rd party or bolt-on solutions to capture electronic signatures.

Does anyone have change control implementation experience in a regulated environment?

Any information or recommendations would be greatly appreciated!


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