CASE STUDY: GLOBAL BIOTECH DEPLOYS KNEAT FOR LABORATORY ASSET LIFECYCLE MANAGEMENT ACROSS ALL ITS GLOBAL LABORATORIES, SUPPORTING THEIR LAB OF THE FUTURE VISION.

ABOUT THE AUTHORS:
Tim Amudala is the Biogen QC Project Manager and Team Leader for the AIV project. He has over 16 years of experience in the life science industry.

Lotte Rosendal is a Sr. Associate in Biogen Quality. She is a champion of innovation and process improvement with more than 30 years of life science industry experience.

Rick Mineo is the founder and president of Encova Consulting. He has provided extensive technical and validation consulting support to the Company.

Sachin Patel is the QC Manager of the AIV team who has provided support to the AIV Core Team. He has over 14 years of pharmaceutical and biotechnology experience.

Christy Mounts provided support to the AIV Core Team. She is the Quality Control Director over the AIV team and is also the Business Process Owner for the Lab of the Future project.

Lou Killian provided collaborative support to the AIV Core Team authors. He is the Customer Success Director at Kneat Software and has over 35 years of life science industry experience at Abbott, Genentech and Biomarin.

 

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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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