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Bx and 21 CFR Part 11 Compliance

Life sciences organizations face challenges such as disrupted clinical studies, growing competition, increased regulation, and increased manufacturing and distribution efficiency. Box can support 21 CFR Part 11 compliance for both electronic records and electronic signatures, providing a single platform for managing regulated and non-regulated content. Box can boost productivity and speed up R&D by converting manual, paper-based processes to digital document workflows. Box has a comprehensive set of over 400 security controls, known as the Common Control Framework, used to assess Box against information security standards and certifications. Box can be configured to help maintain 21 CFR Part 11 compliance for electronic records by enabling a combination of data management features. Box GxP Validation package provides support for 21 CFR Part 11 compliance, in line with FDA's Computer Software Assurance (CSA) guidance and a regular testing strategy.

Life Sciences Organizations: Box Sign:

  • Box enables life sciences organizations to implement digital experiences for all stakeholders, allowing secure sharing, collaboration, and sign-off on projects from anywhere, at any time, and on any device.
  • Box Sign supports compliance with 21 CFR Part 11 requirements, reducing review cycle times, delays, and errors associated with paper-based processes.
  • Key features include: - Requiring all signers to authenticate themselves by logging in to their Box account when applying their signature to every signature field assigned to them. - Providing signers with a list of signing reasons to choose from when applying their signature to every signature field assigned to them. - Displaying an enhanced signature frame that includes signature, signing reason, signatory name, signatory email, and time and date stamps. - Generating an audit log containing all the details associated with the request.
  • Enables participants to sign clinical trial consent forms on the go with the ability to sign on mobile devices.
  • Delivers exceptional patient experiences while eliminating delays associated with paper-based processes.
  • Box Sign can be configured to support 21 CFR Part 11 compliance requirements for electronic signatures by enabling pre-configured controls within the Box Sign settings in the Admin Console.
  • Box GxP Validation customers can also take advantage of additional security, information governance, and workflow capabilities included in the Box Content Cloud.

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