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Name: Validating SharePoint 2013 for 21 CFR Part 11 Environments Date & Time: Friday, 9th August -11:00am EDT (New York), 4:00pm GMT (London), 5:00pm CET (Barcelona) Presenter: Paul Fenton, President & CEO, Montrium Summary: When used as a system for managing regulated content and processes, SharePoint is subject to the requirements of 21 CFR Part 11 and related requirements. During this session we will review the approaches being taken by companies to validate their SharePoint environments, and emerge with a set of guidelines for a risk-based validation strategy for SharePoint. We will explore the differences in approach for cloud based environments versus on premise deployments. You will gain a clear understanding of why, when and how to validate SharePoint, and there will be a strong focus on reducing the time, cost and resources required to validate a SharePoint environment whilst providing maximum quality, control and ROI. Topics will include: Managing and validating a mixed SharePoint environment that includes both controlled and non-controlled SharePoint sites Risk evaluation methods for SharePoint systems A Step by Step overview of the risk-based validation process following the GAMP5 model Implementing effective configuration and change control procedures for SharePoint-based systems SharePoint Online versus SharePoint on-premise Find more at www.montrium.com