Fast DocuSign Validation and SOPs for Clinical-Stage Biopharma Needing GxP System Expertise

USDM’s eSignature system experts helped Xequel Bio streamline its document signing process by efficiently validating DocuSign 33% ahead of schedule, saving the company time and money.

Situation:

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.

Solution:

USDM’s team of experts acted as an extension of Xequel Bio’s team and provided a comprehensive validation of DocuSign, including a Validation Plan, Installation Qualification, and Validation Summary Report. Within two weeks, USDM validated DocuSign and provided valuable training and standard operating procedures (SOPs) for Xequel Bio, 33% ahead of schedule. Rapid validation enabled Xequel Bio to free up their time and resources, allowing them to focus on training their team on SOPs and other critical tasks.

Results:

With the DocuSign validation now in place, Xequel Bio was able to significantly streamline its document signing process, saving valuable time and effort. By working with USDM, they were able to focus on other critical business activities, knowing that their electronic signature software was fully validated with the FDA’s regulatory requirements. Additionally, the team increased their compliance know-how and learned best practices by utilizing trusted experts in GxP technology.