Using DocuSign to Facilitate Compliance with 21 CFR Part 11

DocuSign sets the global standard for electronic signatures and Digital Transaction Management (DTM). Across all industry segments, DocuSign delivers the most trusted and widely used solution available. DocuSign further supports life science organizations' compliance with the e-signature practices set forth in 21 CFR Part 11 with tailored functionality and packaged service offerings. DocuSign's open, standards-based approach makes it easy to integrate compliant electronic signatures, even into complex processes and systems.

DocuSign has partnered with industry experts to deliver transactions which meet FDA regulations. DocuSign’s 21 CFR Part 11 Module contains industry-designed capabilities that include:

  • Pre-packaged account configuration
  • Signature-level credentialing
  • Signature-level Signature Meaning
  • Signature manifestation (Printed Name, Date/Time, and Signature Meaning)

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