DocuSign Part 11 Compliance: Electronic Signatures

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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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