DocuSign GxP

DocuSign and USDM Life Sciences have partnered to enable life sciences companies to streamline regulated business processes and execute signatures using DocuSign’s 21 CFR Part 11 compliant Digital Transaction Management solution. With USDM’s help, DocuSign can become an end-to-end digital e-signature solution for a wide range of GxP use cases including clinical trials, electronic batch records, regulatory filings, training, change control, field service reports, recall notifications, and laboratory procedures.

Customers who use DocuSign in a range of industries report improvements to critical business processes such as:

  • Reduction in turnaround time (TAT) by 13.5 days or 97%
  • Improvement in productivity by more than 61%
  • Reduction of documents in not in good order (NIGO) from 27.5% to 5.1% or 81.6%

It starts with a 21 CFR Part 11 compliant and validated platform. USDM has expanded its VAP and Cloud Assurance program 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 Cloud Assurance offering for DocuSign includes:

  • Validation Accelerator Pack (VAP) / Qualification Package (Validation Plan, requirements, IQ/OQ/PQ, trace matrix)
  • Vendor Audit (updated annually)
  • Validation Maintenance Package (updated as changes are made with new releases)
  • Test automation options
  • Subscription based services that provide the ability to maintain compliance

Learn more about the USDM DocuSign solutions

Download a case study about USDM getting the DocuSign platform qualified and rolling out the first training use case in 18 days

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  • 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…
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