Systems development is at the beginning of its life as a scientific discipline. The pharmaceutical industry has a clear requirement to use validated systems in clinical trials. Validation cannot be regarded as a single event. A systems development life cycle methodology can integrate validation into the design and implementation of a system, matching validation activities with the life cycle of the system. PRA International, Inc. has implemented a system development life cycle developed using the Institute of Electrical and Electronic Engineers standards on software engineering as a guide.
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