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Forums > All Catalyze > Methods & Processes
Subject: FDA 21 CFR Part 11 Validation
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jmalkin
Posts:1
07/23/2008 3:13 PM Alert 

I'm going through the process of creating User Requirements Specification (URS), Functional Requirements Specification (FRS), and Test Scripts to meet FDA CFR Part 11 Validation requirements and I'm thinking there has to be a better way.  Anyone have experience working through a validation project?