Successful software system validation requires the right combination of attitudes, processes, techniques, and tools. This article presents a framework for software validation followed by specific examples and explanations of methods and tools. The use of information control and static and dynamic software analyses is also described. This framework is intended to increase productivity and the likelihood of success during the initial software validation period and for the lifetime of the software system. These methods are based upon experience developing and supporting a major laboratory data management software product.
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