I got this just the other day. It seems to have your questions answered and it is free.
Subject: Free Webinar: SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments
First Webinar in our SharePoint for Pharma Series - SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments - April 23rd @ 1pm EST
Presented by Paul Fenton, VP Pharmaceutical Processes and Technology, Montrium Inc.
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. 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.
Among the topics included will be:
- Managing and validating a mixed SharePoint environment that includes both controlled and non-controlled SharePoint environments
- 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