A clinical-stage biopharmaceutical company that develops targeted cancer therapies to address treatment resistance relies on USDM's Cloud Assurance to maintain the validated state of its Microsoft SharePoint GxP environment. The company has a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies.
The Challenge
The company needed a cost-effective GxP document management solution and wanted to avoid investing in a second, redundant platform. Several constraints shaped the engagement:
- The customer required a cost-effective GxP document management solution.
- They already used Microsoft SharePoint for non-GxP document storage.
- They needed GxP document storage integrated with electronic signature capabilities to support 21 CFR Part 11 compliance.
- Their audit trail would not be maintained indefinitely by Microsoft, creating a data integrity and retention risk.
The Approach
Rather than introduce a new system, USDM extended the customer's existing investment by validating SharePoint for regulated use and closing the e-signature and audit trail gaps. USDM applied a risk-based computer software assurance (CSA) mindset to decrease the time and cost to validate SharePoint Online.
- 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
The company gained a GxP-ready content management platform built on technology it already owned, and a managed-service model to keep it compliant as the environment evolves.
- Optimized existing technology and minimized IT expense while adding GxP functionality.
- Decreased the time and cost to validate SharePoint Online.
- Increased system adoption and speed to use through organizational change management (OCM) training.
By validating SharePoint Online and integrating DocuSign for compliant electronic signatures, USDM turned an existing non-GxP platform into a validated GxP content management solution and now sustains that validated state through Cloud Assurance, so the customer can stay focused on advancing its cancer therapy pipeline.