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APPVALDOCS Project: Application Validation Documents
Submitted by Thomas Grzybowski; posted on Monday, August 16, 2004
The "appvaldocs" project plans to develop model FDA-compliant system validation documentation. Our motivation is primarily to help lower the costs of drug development through the creation of "Open Source" validation materials which are intended to assist in compliance with relevant FDA regulations.
FDA-compliant validation of software is a complex subject, with legal ramifications. We touch on a number of the impediments to the introduction and validation of Open Source Software in the Bio-Pharma industries.
Learn more about the project in this featured article:
http://bioinformatics.org/features/2004/08/16/
If you would like to assist with this project, or just discuss the topic, please contact Thomas Grzybowski:
http://bioinformatics.org/sendmessage.php?touser=14865
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