Streamline Document Signing with Built-In Continuous Compliance

Learn how USDM validated DocuSign for a biotech company with a remote workforce, enhancing efficiency and flexibility.

Situation:

A clinical-stage biotech company was searching for a flexible eSignature solution that could accommodate their remote workforce. With employees continuing to work from home after the pandemic, the biotech company quickly realized that the manual process of signing documents was becoming time-consuming, involving a multi-step process including printing the document, signing it, and scanning it. This burdensome manual process began leading to several delays in critical workflows.

Challenge:

The main challenge for the biotech company was ensuring that their new eSignature platform solution would comply with the FDA’S 21 CFR Part 11 regulation. As a highly regulated company, they needed a solution to streamline the document signing process while ensuring the security and authenticity of their electronic records.

Solution:

The biotechnology company chose DocuSign as their eSignature solution.

Through a recommendation directly from DocuSign, the biotech company selected USDM as the trusted validation partner. By leveraging USDM’s expertise, the customer received the validated DocuSign system. USDM provided a fully validated system, including a Validation Plan, IQ Report, OQ Plan and Report, and a final validation report. In addition, the biotechnology company subscribed to USDM’s Cloud Assurance, a managed subscription that keeps the DocuSign system in a state of continuous compliance.

Results:

Implementing DocuSign as the eSignature solution and the validation services provided by USDM offered many benefits to the clinical-stage biotechnology company, including improved efficiency and enhanced flexibility for their remote workforce.