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The following message was posted to: PharmPK
Does anyone have any opinions or suggestions on achieving Part 11
compliance for NONMEM software.
Best regards,
Phill
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Pharsight has addressed the 21 CFR Part 11 issue for NONMEM (and SAS
and WinNonlin) using its commercial product PKS, a regulatory-
compliant data repository. In short, PKS connects to underlying lab
and other data systems using compliant Connectors. PKS distributes
data to analytical applications including NONMEM using a regulatory-
compliant NONMEM Client. NONMEM analyses are linked to the source
data, and flagged as out of date when the source data change. One
can store scripts and other analysis files as PKS libraries to share
them across studies and analyses.
There is more information available at www.pharsight.com.
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The following message was posted to: PharmPK
Just an FYI. At the AAPS Annual Meeting this year (Tuesday 2 to 4
pm) will
be a roundtable on 21 CFR Part 11 and PK Software.
Peter L. Bonate, PhD, FCP
Director, Pharmacokinetics
Genzyme Corporation
4545 Horizon Hill Blvd
San Antonio, TX 78229
phone: 210-949-8662
fax: 210-949-8219
email: peter.bonate.at.genzyme.com
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