USDM’s eSignature system experts helped Xequel Bio streamline its document signing process by validating DocuSign 33% ahead of schedule—saving the company time and money while delivering full 21 CFR Part 11 compliance.
The Challenge
Xequel Bio, a clinical-stage biopharmaceutical company, wanted to streamline its internal processes with an electronic signature and document management cloud system. The company chose DocuSign and needed assurance that it could be fully validated and used in compliance with the FDA’s 21 CFR Part 11 regulation.
With no in-house validation expertise, the small team of 20 employees needed to validate DocuSign and enable eSignatures across their growing company quickly and efficiently. For a lean organization, standing up a dedicated computer software assurance function internally was neither practical nor fast enough to keep pace with the business.
The Approach
USDM’s team of experts acted as an extension of Xequel Bio’s team and provided a comprehensive validation of DocuSign. The deliverables included:
- Validation Plan defining the scope and strategy for qualifying the system.
- Installation Qualification confirming the system was correctly configured and deployed.
- Validation Summary Report documenting compliant, audit-ready results.
Within two weeks, USDM validated DocuSign and provided valuable training and standard operating procedures (SOPs)—33% ahead of schedule. This rapid validation freed up Xequel Bio’s time and resources, allowing the team to focus on training and other critical tasks. Validating a cloud platform like DocuSign also reflects sound third-party risk management, ensuring a vendor-hosted system meets the same regulatory bar as any internal GxP application.
The Results
With the DocuSign validation now in place, Xequel Bio significantly streamlined its document signing process, saving valuable time and effort. By working with USDM, the team was able to focus on other critical business activities, knowing that their electronic signature software was fully validated against the FDA’s regulatory requirements—with the data integrity safeguards that 21 CFR Part 11 demands.
Just as important, the team increased their compliance know-how and learned best practices by utilizing trusted experts in GxP cloud technology. By delivering a validated, Part 11-compliant eSignature system 33% ahead of schedule, USDM gave a 20-person clinical-stage biopharma the compliance foundation to scale—without the cost and delay of building a validation team from scratch.