“We are living in an era of ‘dumb’ content,” says consultant Nagesh Nama, President of ValiMation, Inc., and who spoke at DIA 2010 in Washington, DC. [Note: Nama's talk preceded that by Novartis' Jim McElroy, featured in yesterday's post on "The Paperless Validation
Lifecycle."].
Problem Definition
A GLP laboratory within a large research establishment comprised of several laboratory systems that are used in GLP studies. This project involved development of a master plan and the compliance infrastructure for the entire GLP organization. It also involved development and implementation of life cycle deliverables for several laboratory systems. The validation effort had the following major stumbling blocks.....
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