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Introducing API Support for 21 CFR Part 11 Compliance in Box Sign

  • June 26, 2026
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Scott Picanco Box
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We are incredibly excited to announce support for 21 CFR Part 11 compliance in Box Sign via the public API, enabling developers in life sciences, pharmaceutical, and healthcare organizations to build e-signature workflows that can support FDA signature requirements within their own custom or third party applications. Users will need GxP Validation enabled in order to leverage this new capability. 

With API support for 21 CFR Part 11 e-signature requests, developers can:

  • Create 21 CFR Part 11 e-signature requests via API using "request_flow": "cfr11"
  • Retrieve and list 21 CFR Part 11 templates with the new request_flow field
  • Leverage e-signature validation with signer reason and is_validated fields
  • Utilize flexible document preparation experiences with the ability to choose between guided or async validation

To learn more about this release, please see 21 CFR Part 11 Requests and Create a Box Sign Request.