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DocuSign Part 11 Compliance: Electronic Signatures


Get advice from our regulatory compliance experts and discover what you need to know about managing electronic signatures.


Pandemic or no pandemic, the ability to sign regulated documentation electronically is a must-have in the life sciences industry.

In our 31-minute video, DocuSign and USDM regulatory compliance experts discuss several aspects of this technology-now approach to business—most importantly, GxP and Part 11 compliance.

Here are the timestamps to help you quickly find answers and solutions for your most pressing questions and use cases.

  • Post-pandemic cloud-now transformation for life sciences (2:50)
  • What does 21 CFR Part 11 mean for regulated businesses? (5:51)
  • Do regulated implementations take longer to deploy? (9:07)
  • What does DocuSign Validator deliver and what does USDM Cloud Assurance provide? (11:40)
  • How can customers demonstrate ROI for their DocuSign investment? (15:30)
  • What are some misunderstandings about the need for a Part 11 solution? (16:30)
  • What is DocuSign’s continuous integration strategy? (20:20)
  • What advice do you have for customers making technology decisions and selecting vendors? (23:15)
  • DocuSign is introducing authentication via SMS. What other innovations are on the roadmap? (27:58)

The Presenters

  • Lacey Carlstrom, Area Vice President, DocuSign
  • David Blewitt, VP of Cloud Compliance, USDM Life Sciences
  • John DiCredico, Product Portfolio Manager, USDM Life Sciences
  • Megha Tak, Product Manager – Part 11 Module, DocuSign

Additional Resources


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