How USDM Helped a Biotech Get Greater ROI on DocuSign and Stay in a Validated State
In 2015, USDM implemented DocuSign for a biotechnology customer and maintained continuous compliance through 2019 with a Cloud Assurance subscription. The customer opted for the minimum managed service package - cloud software release management, risk assessments, and test scripts for core DocuSign functionality - and chose to handle test execution and customer-specific use cases on its own. When that subscription expired, the customer engaged USDM to correct a backlog of missed validation maintenance and perform the test executions needed to bring its DocuSign system current with the FDA's validation requirements.
The Challenge
The customer is a medium-sized biotechnology company focused on enzyme replacement therapies. After its Cloud Assurance subscription lapsed, the company neglected to maintain validation testing execution for DocuSign's cloud-based software updates and fell out of compliance - putting its 21 CFR Part 11 posture and data integrity at risk. It needed rapid remediation to make its DocuSign validated state current again.
At the same time, the company had four years of realized value in DocuSign and wanted greater ROI through deeper integration into other use cases and teams. Its own DocuSign data (shared with permission) made the case for expansion:
- DocuSign was used for both GxP and non-GxP documents.
- Total envelopes sent in 2020 were projected to hit 26,000, a 3-year high.
- More than 1,300 users across the organization.
- Usage was expected to grow by 90% for the 21 CFR Part 11 team, 50% for the Global team, and 8% for the Legal team.
- 35% of envelopes were sent in under 1 hour.
- ~70% of envelopes sent were reviewed, signed, and completed within 24 hours.
- GxP envelopes had a 32% faster turnaround time.
Gaps in successful envelope transaction rates also pointed to the need for a workflow assessment.
The USDM Approach
USDM pinpointed exactly where the customer had stopped executing tests on its Validation and Verification Plan (VVP), then remediated the VVP for every month the customer was behind and performed the applicable test executions to close the gap.
- 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 took over all DocuSign system-update assessments - including operational qualification (OQ) and performance qualification (PQ) testing - to minimize the customer's compliance burden and keep the system in a continuously validated state, an approach aligned with modern computer software assurance (CSA) thinking.
- USDM conducted a Lean IS Health Check across the organization to gauge the relative state of regulatory compliance and IS efficiency, and to identify areas for greater use and integration of DocuSign.
Because cloud vendors push frequent updates, ongoing release assessment is the linchpin of staying compliant. That is the core of USDM's Cloud Assurance approach - and part of a broader third-party risk management strategy for validated SaaS systems.
The Results
- Increased productivity - ~70% of envelopes completed within 24 hours, with 32% faster turnaround on GxP envelopes.
- Greater ROI - ~49% expanded DocuSign usage across the organization.
- Current and maintained - DocuSign updates are current and ongoing maintenance is handled by USDM.
By restoring the customer's validated state and absorbing the ongoing OQ/PQ and release-assessment workload, USDM turned a compliance liability into a faster, higher-ROI eSignature program - while keeping the system continuously audit-ready. Talk to USDM about keeping your validated DocuSign and SaaS systems compliant as the cloud changes underneath them.
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