Blog • Generis Group

Are you struggling with finding a fully validated Requirements Management Tool? • Generis

Written by Generis | August 3, 2017 3:27:37 PM Z

“Validation is required, as regulated by FDA, to ensure that a company’s product development software/system will meet its intended purpose. The software/system must show that it will function in a reliable, consistent manner and is in compliance with regulatory and business requirements. Additionally, once the software/system has been accepted and released for use, there is a need to maintain compliance and fitness throughout its operational life. Unfortunately, information on how to develop a validation plan and the activities expected as part of a validation effort are limited and subject to misinterpretation.”

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