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Good morning, everyone.
There was a thread in 2000 that addressed the validation and 21CFR11
compliance of WinNonLin.
In a more general sense, I am curious how you PK consultants are (or
aren't) attempting to comply with 21CFR11. I know that some have the
resources to write in-house tracking software. In the course of
using NONMEM, WinNonLin, USC-PACK, Kinetica, or in-house macros what
are others doing to comply with this reg?
Are there off-the shelf user-tracking programs that are acceptable to
Are you avoiding the issue by sticking to hard-copy?
Thanks in advance.
Paul R. Hutson, Pharm.D.
UW School of Pharmacy
777 Highland Avenue
Madison WI 53705-2222
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