Michael P. Zwetkow

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Montrium INC.
Chief Innovation Officer
Michael Zwetkow, Chief Innovation Officer at Montrium, Inc., has broad life sciences industry experience, starting as a Validation Consultant at Invensys, Inc. over 20 years ago. As a consultant, he had the opportunity to work across the globe with numerous life sciences organizations, helping them establish effective validation strategies for computerized systems. Mike joined Montrium 11 years ago as the Vice President of Operations and was responsible for overseeing the delivery of technical services, focusing on the implementation of solutions that support clinical trial processes, as well as pharmaceutical and medical device development. He has a mechanical engineering degree from McGill University in Montreal, Canada. Mike has been an ISPE member since 2003.

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Figure 1: Key characteristics of the ISO/IEC 25010:2011 product quality model
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Quality Agreements for SaaS Solutions Intended for GxP Use

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...