Kevin W. Roberson

Eurofins BioPharma Product Testing - Columbia
Senior Director, Quality Systems
Kevin Wm. Roberson, Senior Director, CGMP Quality Assurance. Mr. Roberson joined EAG (formerly Analytical Biochemistry Laboratories) in 2001. Prior to joining EAG, Mr. Roberson spent six years at Protein Design Laboratories where his last two years were spent as the Director, Quality with overall responsibility for Quality Control and Quality Assurance for a multi-product GMP pilot plant. Before Protein Design Laboratories, Mr. Roberson had 6 years of experience at Synergen, Inc. and two years of experience at Monsanto in Quality Control and Analytical development in support of biopharmaceutical development. In addition to Mr. Roberson’s Quality duties at Synergen and Protein Design Laboratories, he also served as a member of many product-development cross functional teams and was instrumental in writing, reviewing, and approving CMC sections for more than a dozen regulatory filings for FDA and international regulatory bodies. Mr. Roberson received a BA and an MA, Biology from University of Missouri Columbia.

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Figure 1: Key characteristics of the ISO/IEC 25010:2011 product quality model
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As adoption of cloud technology continues to increase across the life sciences industry, so too does the need to establish a standardized and pragmatic approach for ensuring the quality of software applications used in support of GxP data and associated processes. This article focuses on the application level and the growing use of software as a service (SaaS) within the life sciences...