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The following message was posted to: PharmPK
Dear Group members,
I have a query regarding validation of WinNonlin. We are currently
using WinNonlin version 4.1 and have validated it using standard
validation kits available from pharsight. The software has been
loaded on a validated desktop. I would like to know at what frequency
we should revalidate WinNonlin. If we keep the same version and don't
make any major changes in the Operating systems, then do we need to
revalidate WinNonlin at any regular interval? What are the regulatory
requirements in this case.
Thoughts from the group would be highly appreciated.
Regards
Dr. Tausif Ahmed
Metabolism and Pharmacokinetics Department
Ranbaxy Research Laboratories, India
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The following message was posted to: PharmPK
Hello,
Please refer to the following set of presentations for some tips.
http://www.ecpag.org/presentations.php?year04w&session=2
You probably are referring to installation qualification (IQ) and
there are
certain recommendations in these presentations on how to perform IQ.
Hope this helps
Joga
Please note the new address and phone below:
Joga Gobburu
Pharmacometrics, OCPB, FDA
10903 New Hampshire Avenue, Building 21, Rm. 4524
Silver Spring, MD 20903-0002
Ph: 301-796-1534
email: jogarao.gobburu.-at-.fda.hhs.gov
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Dear Dr. Tausif Ahmed :
When maintenance is performed on the computer system in terms of new
software releases, the specific validation effort necessary for each
release is determined by the type of changes in the release, e.g.,
defect corrections and/or enhancements. The extent of the validation
effort required for the new release will be determined in a change
control
activity. Sufficient regression testing should be conducted.
When any change (even a small change) is made to the software, the
validation status of the software needs to be re-established.
Whenever software is changed, a validation analysis should be
conducted not just for validation of the individual change, but also
to determine the extent and impact of that change on the entire
software system. Based on this analysis, the [user] should then
conduct an appropriate level of software regression testing to show
that unchanged but vulnerable portions of the system have not been
adversely affected.
The specific validation effort necessary for each software change is
determined by the type of change, .... and the impact of those
products on the operation of the software.
The WinNonlin application only needs to be revalidated if you change
to another version of the software, or if you make changes to the
environment in which the WinNonlin software operates, e.g., the
operating system. Note that revalidation may be required after any
change to the operating system, not only after a major change, as
stated in the original posting. To determine if/when revalidation is
required, and the extent of revalidation required, use your company's
change control process to assess and document the potential impact of
any change on the validated computer system and respond accordingly.
Pharsight Corporation, the vendor of the WinNonlin software, offers a
WinNonlin 5.0.1 Validation Suite product to assist WinNonlin
customers with the validation of WinNonlin 5.0.1 at their user
sites. Validation products are not available for previous versions
of WinNonlin.
(Note that this guidance document "General Principles of Software
Validation; Final Guidance for Industry and FDA Staff" was issued by
FDA CDRA; no final guidance documents have been issued by CDER or
CBER on the topic of software/computer system validation. But, since
this guidance document is based on generally recognized software
validation principles, it can be applied to any software.)
Best regards,
Debra Fontana
Pharsight Corporation
Quality Assurance/Quality Engineering Manager
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)