CFR part 11 and CUP

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

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:
U.S. Food and Drug Administration (FDA) Title 21 Code of Federal Regulations (CFR) Part 11 [original link is broken]
Regards,
Raghu
Edited by: Raghu Boddu on Aug 3, 2011 7:20 AM

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