Successfully reduce project timelines and minimize validation costs with our framework...

Lessons from over 30 SharePoint Validation Projects in the Life Sciences

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 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 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.

This webinar is packed full of insightful content:

  • 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

Presented by:


Michael Zwetkow

VP - Professional Services & Alliances 

Michael Zwetkow has over 15 years industry experience and currently heads up the Professional Services group at Montrium. Michael graduated with a Mechanical Engineering degree from McGill University in Montreal, Canada. He has worked across the globe with some of the larger pharmaceutical companies, as well as numerous medium and smaller sized biotech companies.