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

In Generis, generis group, Life sciences, manufacturing, manufacturing operations, medical device, medtech, mfg, Uncategorized by Generis0 Comments

“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.”

Are you struggling with finding a fully validated Requirements Management Tool? If so, check out the full white paper by Cognition! 

 

 

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