Learn how USDM helped a clinical-stage immunotherapeutic company implement an electronic document management system (EDMS), minimizing the company’s validation expense by 33% and creating significant productivity efficiencies.
A clinical-stage immunotherapeutic company with a small Quality Assurance team and no in-house IT team needed a cost-effective solution to manage its electronic document management system in compliance with the FDA's 21 CFR Part 11 regulation.
The Challenge
The customer needed assistance with the initial implementation and cloud release maintenance of DocuSign. The company required support with its validation activities related to 21 CFR Part 11, ensuring that the software remained in a state of continuous compliance. The customer was hesitant to hire a one-time implementation consultant because they needed ongoing validation maintenance for DocuSign and continued GxP technology guidance — areas where strong data integrity practices are essential. The company needed to implement DocuSign quickly and could not wait to stand up a proper in-house team to achieve this business requirement.
The Approach
USDM's team of experts provided the customer with a cost-effective, rapid solution for the initial validation implementation activities. Applying a risk-based computer software assurance (CSA) mindset, USDM delivered a fully validated DocuSign system, including a Validation Plan (VP), an Installation Qualification (IQ), and a Validation Summary Report (VSR).
Given that the customer did not have the internal resources to also handle the ongoing monthly cloud updates from DocuSign, USDM managed all of the customer’s releases to keep their DocuSign system continuously compliant with Cloud Assurance. USDM’s Cloud Assurance subscription offloads the management of DocuSign releases and includes automated regression testing to keep the customer in a continuously validated state — removing the burden of vendor release monitoring from a lean team.
The Results
- The customer reduced their validation costs by 33%.
- The customer saved over 50 hours of administration workload in their first 2 months by eliminating paper printing, wet signatures, and scanning of documents.
- The customer processed 200 envelopes in the first 2 months using DocuSign for GxP business needs. With the industry average cost of a wet signature at $50, the customer quickly recognized $10,000 in value.
- The customer achieved 50% faster signature execution, increasing productivity.
In our customer’s words:
"This project has been a breath of fresh air. It was smooth and easy to understand what we needed to do." -Quality Assurance Lead
“Feedback on this project was consistently positive, and my team appreciated that they were kept informed and their questions were always answered in a timely fashion.” -VP of Quality and Compliance Management
Compliance that scales with you
By combining rapid validation with ongoing release management, USDM turned a one-time DocuSign deployment into a durable, audit-ready capability — letting a small Quality team stay focused on the science while their EDMS remained continuously validated. Talk to USDM about keeping your GxP cloud applications in a continuously compliant state.