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FDA 21 CFR Part 11 Compliance

Question asked by mstoakes on May 17, 2007
Latest reply on May 17, 2007 by mstoakes
I'm interested in deploying Alfresco in an FDA regulated environment, and the current release seems to be 21 CFR Part 11 complaint except for one feature. Alfresco doesn't have a digital signature capability. Does anyone know of a third party module that allows Alfresco to meet the Part 11 requirement for digital signatures?

If the Alfresco folks added this capability, there could be tremendous revenue from the pharmaceutical industry in the form of validation services, training, and support. This is a curious gap in the feature set especially since one of the founders and developer come from Documentum, which has a strong presence in the pharma space.

Give me Part 11 compliance or give me death! (apologies to Patrick Henry)