Are you looking to use Microsoft (Office) 365 to manage GxP content?

Download the Microsoft 365 GxP Guidelines fuel your digital transformation!

The Guidelines will help you to establish a GxP governance and compliance strategy for the Microsoft 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.

The Guidelines cover:

  • Microsoft 365 system overview with supporting certifications and attestations
  • The technical and procedural controls available to maintain control
  • Implementing a GxP compliance lifecycle
  • Roles & responsibilities of both the client & Microsoft
  • Governance policies and procedures
  • Consideration for the validation of GxP applications including GAMP 5