Validation Basics: A System Developer's Approach to Validation

Validation is required for computer systems to create,modify, maintain, archive, retrieve, or transmit data  intended for submission.To ensure that the quality assurance–quality control andthe information technology departments speak the same language,a system developerwill build documented evidence that a system’s functionality has been tested, performs as specified,and  generates reproducible results.


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Author(s): 
Christopher L.Gent.
Journal: 
Pharmaceutical Technology JULY 2002 .