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The purpose of this document is to demonstrate that Microsoft has the necessary technical and procedural controls to maintain the Office 365 platform, including SharePoint Online and OneDrive for Business applications, in a state of control.

The Guidelines will help you to establish a GxP governance and compliance strategy for the Microsoft Office 365 software service, to help you remain compliant in using Microsoft cloud services for content management. The document also identifies customers' shared responsibilities with Microsoft for meeting the regulatory requirements of 21 CFR Part 11 and Annex 11.

With these Guidelines, you will learn:

  • Office 365 system overview with supporting certifications and attestations
  • Implementing an Office 365 GxP compliance lifecycle
  • Roles & responsibilities of both the client & Microsoft
  • Governance policies and procedures
  • Consideration for the validation of GxP applications including GAMP 5