Demystifying Software Validation

July 1, 2017
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LCGC E-Books
Volume e5, Issue 4

The term “software validation” can trigger many responses, including confusion and even anxiety. What is the difference between qualification and validation? Which systems need to be validated? When do systems need to be revalidated? How much validation work is enough? This article provides a foundation for thinking critically about system definitions and software validation, including discussions on the differences between qualification and validation, risk-based validation, and revalidation.