For those who have learned the “what” and “why” of computer system validation, this paper will concentrate on the next step— “how” to validate a computer system. The following topics will briefly be reviewed: validation and verification perspectives, test phases and the differences between them, and how testing activities fit into a software development methodology and improve system quality. With this as a background, a six-step approach to validating software applications will be introduced. Throughout this discussion, examples based on a clinical software application system will be used to illustrate specific steps in the validation process.
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