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Dear All,
We want to validate WinNonlin. We have the validation kit from
Pharsight and we already ran it. One of the question that we have
difficulty to answer is how far do we need to go. WNL is a software
that has been used for ages, hence do we really need to validate its
functions or just the data transfer?
We would really like to know what the other companies have done (if
anything :-) ) with re to that. Also, what is the position of the
regulatory authorities, especially FDA and EMEA?
Thanks in advance for your help
Nathalie Toublanc
UCB pharma
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The following message was posted to: PharmPK
Bonjour Nathalie,
You need to validate the parts that you will be using to support
regulatory
submissions. If you won't be using the table generator or the linear
mixed
effects capabilities, for example, then you could leave those out of
your
validation plan.
Amities...
Brian Sadler
Strategic PK Consulting, LLC
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The following message was posted to: PharmPK
Nathalie,
I am not sure what process others have done to validate "over the
counter"
software, e.g. WinNonlin, but the web is full of useful information on
the
topic of software validation/verification. The FDA Guidance for
validating
software can be found at http://www.fda.gov/cdrh/comp/guidance/938.pdf.
If
you are interested in a company that has performed software validation
complying to FDA guidelines, you can check out Analex
(http://www.analex.com/html/med_software_v_and_v.html). They have
additional reading on issues of software validation. A summary and
plain
explanation of the FDA Guidance can be found at
http://www.analex.com/assets/images/RoadmapCompVal.pdf, and specific
details
related of the validation of "over the counter" software can be found at
http://www.analex.com/assets/images/COTS.pdf.
Hope the information helps to get you started.
Cheers -Jon
Jonathan Monteleone (MS), j.monteleone.at.auckland.ac.nz
Dept of Pharmacology & Clinical Pharmacology, School of Medicine
85 Park Rd, Private Bag 92019, Auckland, New Zealand
Work phone: +64 (9) 3737599 ext 86732
Pharmacometric Resources at
http://www.health.auckland.ac.nz/pharmacology/staff/nholford/pkpd/
pkpd.htm
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)