Challenge: A Manual Signing Process That Couldn't Keep Up
A clinical-stage biotechnology company was searching for a flexible eSignature solution that could accommodate its remote workforce. With employees continuing to work from home after the pandemic, the company quickly realized that the manual process of signing documents had become time-consuming, involving a multi-step workflow: printing the document, signing it, and scanning it. This burdensome manual process began creating delays in critical workflows.
As a highly regulated organization, the company faced a second, equally important hurdle: any new eSignature platform had to comply with the FDA's 21 CFR Part 11 regulation. The team needed a solution that would streamline document signing while preserving the security and authenticity of their electronic records, with the data integrity a regulated business depends on.
Approach: Validate DocuSign, Then Keep It Compliant
The biotechnology company chose DocuSign as its eSignature solution. Through a recommendation directly from DocuSign, the company selected USDM as its trusted validation partner.
By leveraging USDM's expertise, the customer received a fully validated DocuSign system. USDM applied a risk-based computer software assurance approach and delivered a complete validation package, including:
- A Validation Plan
- An IQ Report
- An OQ Plan and Report
- A final validation report
Validation alone, however, is a point-in-time achievement. To ensure the system stayed compliant as it evolved, the biotechnology company subscribed to USDM's Cloud Assurance, a managed subscription that keeps the DocuSign system in a state of continuous compliance through every vendor update and change.
Results: Faster, More Flexible, and Audit-Ready
Implementing DocuSign as the eSignature solution, combined with the validation services provided by USDM, delivered several benefits to the clinical-stage biotechnology company:
- Improved efficiency by replacing the print-sign-scan workflow with a validated digital process
- Enhanced flexibility for a remote workforce that no longer depended on physical documents
- Sustained 21 CFR Part 11 compliance maintained through USDM Cloud Assurance well past go-live
With a fully validated eSignature system and continuous compliance built in, the biotechnology company turned a slow, manual bottleneck into a fast, flexible, and audit-ready workflow, freeing its remote teams to keep critical work moving.