PharmPK Discussion - Validation of data acquisition systems within a bioanalytical lab

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On 9 Dec 1999 at 10:25:10, "Hui, James" (James.Hui.-at-.solvay.com) sent the message


Does anyone have any advice concerning procedures for validation of data
acquisition systems to be used in a GLP bioanalytical laboratory setting?
How are bioanalytical group leaders addressing 21 CRF Part 11 concerning
handling of electronic data?

Specifically, are there any concerns with Hewlett-Packard systems
(ChemStations) since they have no audit trail available for electronic
storage of raw data?  What about data acquisition systems for LC/MS/MS
instruments, for which raw data audit trails are not available?  Which
systems are best to use to remain in compliance with 21 CFR Part 11?  What
are the advantages/disadvantages of the popular systems presently available
-  e.g. TurboChrom, Millennium, PeakPro?  I would like to initiate some
discussion on this very timely and critical topic related to bioanalytical
laboratories.

James Hui, Ph.D.
Director, Drug Disposition and Safety
Solvay Pharmaceuticals, Inc.
901 Sawyer Road
Marietta, Georgia 30062
Phone: 770-578-5942
EMail:  james.hui.aaa.solvay.com

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On 9 Dec 1999 at 22:30:23, Andy Vandiver (AVandiver.aaa.qualicaps.com) sent the message


James,

You may want to try this URL address
http://www.oecd.org/ehs/ehsmono/

It has several articles concerning GLP's.  In the September Issue of
Pharmaceutical Technology, there is an article regarding the many
Computer Validation Resources on the Internet.  It has a lot of links --

Good luck,
Andy Vandiver

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