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!