DocuSign and USDM Life Sciences have partnered to enable life sciences companies to streamline regulated business processes and execute signatures using DocuSign’s Digital Transaction Management solution. USDM has expanded its VAP and Cloud Assurance offering to include a Validation Accelerator Pack (VAP) and compliance offering for DocuSign that enables DocuSign customers to meet 21 CFR Part 11 and can be easily implemented and validated.

The USDM Life Sciences DocuSign VAP provides the components and services required to rapidly and cost-effectively meet FDA regulatory requirements associated with the validation of DocuSign:

  • DocuSign Validation Plan template defining the validation strategy and deliverables
  • Functional Requirement Specification (FRS) template tailored to life sciences application requirements
  • Risk Assessment template to address the basis for testing against the FRS requirements
  • Trace Matrix template to track the satisfaction of these requirements in the USDM Life Sciences DocuSign test protocols
  • Installation Qualification protocol template to document and verify your installed configuration of the application
  • Operational Qualification protocol template to document and verify the functionality of DocuSign
  • Performance Qualification protocol template to verify end-to-end business processes across DocuSign modules, representing the field service product lifecycle
  • Validation Final Report template to summarize the results of the validation effort
  • Standard Operating Procedure templates ready to tailor to your operations
  • Optional subscription to update validation scripts for new DocuSign releases
  • Annual Supplier Audit reports of DocuSign by USDM, as required by FDA regulations and GAMP guidelines
  • Available automated testing tools for DocuSign to facilitate rapid re-validation of DocuSign for new releases
  • USDM Life Sciences consulting services to help design business processes in DocuSign and expedite the tailoring of the VAP templates to your configured DocuSign system, and facilitate test script execution

Download the USDM Life Sciences DocuSign Overview Pamphlet



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials