A Case Study on Implementation of an electronic Solution for Validation Life Cycle Management resulting in Productivity improvements greater than 100%, Cycle Time improvements greater than 50% and Equipment Change Over resource cycle time efficiency improvements of 85%.

ABOUT THE AUTHORS:
Adam Tessneer is the Sr. Manager Quality Engineering at Biogen. He is also the Champion and Business Process Owner for the e-validation VLMS Solution and validation business process. He can be contacted at Adam.Tessneer@biogen.com

Rick Mineo is the founder and president of Encova Consulting. He has provided extensive technical and validation consulting support to the Company. He can be contacted at mineor@encovaconsulting.com

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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Case Study: Validation Process Innovation in Molecular Diagnostics:
Implementing a new and innovative Computer System Validation (CSV) and Change Management program at a Molecular Diagnostics Company. Transitioning the overall validation process from paper based to an e-Val system.

ABOUT THE AUTHORS:
Shane Pew is the Quality Director for Myriad 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 company. Shane can be contacted at mmshanep@myriad.com.

Lou Killian provided collaborative support to the Company for authoring of this case study. He is the Customer Success Director at Kneat Software and has over 35 years of Life Sciences experience at Abbott, Genentech and BioMarin. Lou can be contacted at lou.killian@kneat.com.

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