Gianna De Rubertis

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Montrium
Director Professional Services
Gianna De Rubertis, ing, has over 18 years of industry experience, working as a validation and quality systems consultant. Gianna has extensive experience in the validation of computerized systems, manufacturing equipment, and utilities. Recent projects have focused on the implementation and validation of SaaS solutions for electronic document management and electronic signatures. Gianna is currently the Director, Professional Services, at Montrium, Inc. She holds a degree in chemical engineering from McGill University and a master of applied science degree from the University of Toronto. Gianna has been an ISPE member since 2010.

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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...