How does FirstDoc “do” 21 CFR Part 11 compliance?

21_CFR_Part_11_compliant

CSC have published (not recently) a whitepaper about the capabilities that FirstDoc products provide for compliance with the FDA’s ruling on Electronic Records and Electronic Signatures (fondly known in the Pharma industry as “21 CFR Part 11”).

The whitepaper is a good one. It starts off with a recap of what is contained in 21 CFR Part 11, and then does an itemised breakdown of the capabilities that the FirstDoc products have to meet the compliance requirements.

You can download it here.

21 CFR Part 11 Compliance Position for FirstDoc Applications

Related Post: FirstDoc, FirstPoint, NextDocs – a “rough notes” comparison

Check this out:
FirstDoc User Group 2011 - a look back at the conference - Part 4