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Validation of SharePoint for GxP Content Management Solution

An Introduction to Software Validation

Clinical-stage biopharmaceutical company relies on USDM’s Cloud Assurance to maintain its validated state of their Microsoft SharePoint GxP environment.

The company develops targeted cancer therapies to address treatment resistance and to improve lives. They have a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies.

The Situation
  • Customer required a cost-effective GxP document management solution.
  • They already used SharePoint for non-GxP document storage.
  • Customer needed GxP document storage integrated with electronic signature capabilities.
  • Their audit trail would not be maintained indefinitely by Microsoft.
The Solution
  • USDM validated SharePoint as a GxP content management solution.
  • USDM integrated DocuSign as a GxP compliant e-Signature solution with SharePoint.
  • USDM provided program and project management to ensure seamless implementation and onboarding.
  • USDM developed training material for the customer’s employees to drive adoption of the new system.
  • USDM created and deployed a PowerShell script to export audit trail documentation to a secure location.
  • The customer subscribed to USDM’s Cloud Assurance™ managed service to maintain their validated state for SharePoint after the initial implementation and validation.

The Results

  • Optimized existing technology and minimized IT expense while adding GxP functionality​
  • Decreased time and cost to validate SharePoint Online​
  • Increased system adoption and speed to use with OCM training

Learn more about the benefits of validating SharePoint for life sciences companies.


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