By BRITNEY on Sunday, December 9, 2001 - 10:40 am:
CAN ANYBODY GIVE ME LINKS FOR COMPUTER VALIDATION FOR HPLC SYSTEMS. THANKS IN ADVANCE FOR THIS GREAT HELP.
By Tom Mizukami on Monday, December 10, 2001 - 09:48 am:
www.labcompliance.com
By jschibler on Monday, December 10, 2001 - 10:18 am:
Britney -
Ludwig Huber's site http://www.LabCompliance.com has a lot of useful content and links; he's been focused on the topic for many years. Rob McDowall published a series of compliance-related articles in LC/GC, available online at http://www.lcgcmag.com/articles/9904_articles/9904_McDowall_cds/9904_McDowall_cds.asp. If you're not looking to do the work yourself, there are numerous other consultants in the business; a Web search should give you plenty of hits. A product I market has some very nice automated IQ/OQ/PQ functions for validating the software, the instruments, and the method; some further information is provided in a Technical Note on 21 CFR 11 Compliance that you can download from http://www.dionex.com/app/tree.taf?asset_id=12451.
I hope you find these resources helpful.
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