Do I Need To Validate? How To Make An Informed Decision In 4 Steps

By Erin Wright

Nobody ever said software validation is easy. Like most of you, I was conditioned to accept the “traditional” validation approach, the kind that requires a tremendous amount of documentation, arduous writing of functional test scripts, and nervewracking execution of test protocols. Such cumbersome work lasts up to four months for companies that upgrade every two or more years.

Validation is twice as tough if you are plagued by uncertainty and asking yourself: do I really need to validate? It’s a legitimate question, which I’ve encountered throughout my career as a validation professional. I will walk you through the necessary thought process to make an informed decision.