Demystifying Software Validation


LCGC E-Books

LCGC E-BooksLCGC E-Books-07-01-2017
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.


Read more in LCGC’s new eBook, Reduce Risk in a Data Integrity World:Approaches to Ensure Compliance here.

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