Learn how USDM helped a biotech customer achieve greater ROI on DocuSign and maintain their validated state

In 2015, USDM implemented DocuSign for a biotechnology customer and maintained continuous compliance with our Cloud Assurance subscription through 2019. The customer opted for the minimum managed service package, which included cloud software release management, risk assessments, and test scripts for the core DocuSign functionality. The customer chose to handle test execution and customer-specific use cases on their own. Upon expiration of their Cloud Assurance subscription, the customer engaged USDM to correct their backlog of missed validation maintenance requirements and perform the necessary test executions to get their DocuSign system current with the FDA’s validation requirements. 

The Situation
  • A medium-sized, biotechnology company focused on enzyme replacement therapies
  • The company neglected to maintain their validation testing execution for DocuSign’s cloud-based software updates and fell out of compliance
  • The company needed rapid remediation to make their DocuSign validated state current
  • The company had four years of realized value in DocuSign and wanted to get greater ROI out of DocuSign with deeper integration into other use cases and teams across the company
    • Customer’s DocuSign data that supports their investment (shared with permission)
      • Customer used DocuSign for GxP and non-GxP documents
      • Total number of envelopes sent in 2020 was projected to hit 26,000, a 3-year high (includes GxP and non-GxP use)
      • More than 1,300 users across the organization
      • DocuSign usage was expected to grow across the company by:
        • 90% for 21 CFR Part 11 team
        • 50% for Global team
        • 8% for Legal team
    • 35% of envelopes were sent in under 1 hour
    • ~70% of envelopes sent were reviewed, signed, and completed within 24 hours of being sent
    • GxP envelopes had 32% faster turnaround time
    • Gaps in successful envelope transaction rates identified the need for a workflow assessment
The Solution
  • USDM assessed the point at which the customer stopped doing the test executions on the Validation and Verification Plan (VVP)
  • USDM handled the remediation of the VVP for each month they were behind
  • USDM performed the applicable test executions
  • USDM used the customer’s internal DocuSign Part 11 system to get VVPs approved more quickly, saving ~75% in waiting time for documents to be signed
  • USDM is now handling all DocuSign system update assessments, including the operational qualification (OQ) and performance qualification (PQ) testing on behalf of the customer, minimizing their compliance burden, and keeping them in continuously validated state
  • USDM conducted a Lean IS Health Check across the organization for an indication of the relative state of regulatory compliance and IS efficiency, and to identify areas of greater use and integration of DocuSign

70% of envelopes completed within 24 hours

32% faster turnaround on GxP envelopes

Greater ROI with ~49% expanded DocuSign usage

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