Validation Resources

A while back there were a few emails relating to systems validation. I thought it might be worth sharing this document with the list:

GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS

http://www.picscheme.org/publication.php?download&file=cGktMDExLTMtcmVjb21tZW5kYXRpb24tb24tY29tcHV0ZXJpc2VkLXN5c3RlbXMucGRm

Our local Health Canada inspector tells me that this document is used by Health Canada and many other regulatory agencies as the basis for their inspections. For those of you interested in validation it might be worth a read!

Rick.

Rick Watts B.Sc, FICR, CSci
Team Lead, Clinical Research Informatics Core
Women & Children's Health Research Institute
University of Alberta
1047 RTF, 8308 114 Street
Edmonton, AB Canada T6G 2V2
Tel: (780) 248 1170
Fax: (780) 407 1982
http://cric.med.ualberta.ca
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