on 08-02-2011 8:23 PM
Hi Gurus,
Can you please let us know whether the CUP tool is CFR part 11 compliant?
Hi,
while CUP does not do digital signatures (i.e. cryptography and all that) you can configure it to use an additional userID/password confirmation when approving a request.
FDA will consider this a valid electronic (note the difference) signature in the sense of FDA 21 CFR Part 11. We have implemented this at several multi-national pharmaceuticals already.
Frank.
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Hi,
Since CUP has electronic signatures and electronic records, I hope it is complaint to CFR 11.
But, CFR Part 11 deals with majorly Food and Drug Administration (FDA) guidelines, which means it is a specific industry compliance. So not very sure
Check this link:
Regards,
Raghu
Edited by: Raghu Boddu on Aug 3, 2011 7:20 AM
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