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Case Study: Validation Process Innovation in Molecular Diagnostics

Lou Killian
,
Shane Pew
Aug 28, 2017 7:00 am EDT

A leading and pioneering Molecular Diagnostics Company with a reputation for innovation, responded to the increasing regulatory oversight on its industry by performing a 360-degree review of all its GxP testing processes, with the goal to make them best in class.  An early focus was Computer System Validation (CSV).

Based on the vision, this process was re-engineered and in parallel transitioned into a fully electronic system.  The result was a streamlined compliant and efficient end-to-end paperless process.

Click here to read the full case study to learn about their strategies implemented, benefits realized, and more.

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Lou Killian
Lou Killian is the Customer Success Director at Kneat Software. He has over 35 years of Life Science Industry experience at Abbott, Genentech and BioMarin. Lou can be contacted at lou.killian@kneat.com
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Shane Pew
Shane Pew is the Quality Director for the Company with over 18 years’ experience in Life Sciences. He is also the Champion and Business Process Owner for the e-platform and the validation business process at the...
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Source URL: http://www.ivtnetwork.com/article/KNeat%20-case-study-validation-molecular-diagnostics