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Dear All,
Is Performance Qualification required for Winnonlin Software?
With Regards
N.Ramesh
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The following message was posted to: PharmPK
Pharsight now provides validation kit. You can use the same for
validating WinNonlin.
As per guidelines, you need to perform IQ, OQ and PQ also.
Regards
Tausif Ahmed, Ph.D.
Principal Scientist, DMPK
Sai Advantium Pharma Ltd., Pune
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It is good business practice to qualify software whether or not you
are using the data for submission. If you are using the data to
support a submission the software must be validated. Pharsight does
sell a validation package-or you can find someone to validate using a
different but validated software-SAS, Excel, etc. which can be more
rigorous and less suspect than using the manufacturer's software to
validate the manufacturer's software.
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