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CFR part 11 and CUP

Former Member
0 Kudos

Hi Gurus,

Can you please let us know whether the CUP tool is CFR part 11 compliant?

Accepted Solutions (1)

Accepted Solutions (1)

koehntopp
Product and Topic Expert
Product and Topic Expert
0 Kudos

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.

Answers (1)

Answers (1)

Former Member
0 Kudos

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:

[original link is broken]

Regards,

Raghu

Edited by: Raghu Boddu on Aug 3, 2011 7:20 AM