SamCoverdale

Capturing Validated Approvals (Regulatory Requirements)

Discussion created by SamCoverdale on Sep 25, 2012
Latest reply on Sep 27, 2012 by Chris_Hackett
Question for the Clarity guru's,

Is anyone using Clarity to manage document approvals that comply with FDA requlation (21 CFR Part 11)? Is it possible?

The key part is that when a user approves the deliverable, then they are prompted to re-enter their username and password. At that point the approval is locked and timestamped and ID captured.

Any suggestions to around making this work with as little customization as possible? Has anybody tackled anything similar?

Sam

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