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The following message was posted to: PharmPK
Dear all,
I wonder what the experience is in your lab or production facility with
validation and CFR part 11 compliance of personally developed excel or
access applications.
These are hard to validate programs. One can think of password
protection of the sheet or directory where it is stored, but because
changes can be easily made preferably an audit trail and electronic
signatures are implemented.
I wonder what your experience is with these issues. Has anyone tried
third-party addons for implementation of audittrails and electronic
signatures? What other QA actions have you taken to assure part 11
compliance?
Sincerely,
Rob ter Heine
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Rob ter Heine, PhD, PharmD
Meander Medical Center, hospital Pharmacy
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The following message was posted to: PharmPK
Robert:
It might a good idea to pose your question to the Yahoo Part 11 News
Group, 21cfrpart11.aaa.yahoogroups.com
They have discussed similar issues a number of times in that forum.
Vince
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The following message was posted to: PharmPK
Dear Rob,
You are right in saying that Excel applications are difficult to
validate. We have validated "Excel templates" used for bioanalytical
and pharmacokinetic calculations.
After validating these templates, these were placed at secured
locations by the administrator. Users could use only "read-only" copy
of these templates.
Comments from other group members are welcomed.
Regards
Tausif Ahmed, Ph.D.
DMPK
Sai Advantium Pharma Ltd., Pune
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