Box, Inc., the leading Content Cloud, today announced that its native e-signature product, Box Sign, has achieved support for compliance with FDA 21 CFR Part 11 regulations for electronic signatures. Available as part of the Box GxP Validation offering in the Box Enterprise Plus plan, the newly released Part 11 e-signature workflow capabilities in Box Sign offer functionality and controls which, if properly configured and used, enable users to create e-signatures compliant with the requirements of Part 11.

“Box Sign Part 11 gives teams complete control, visibility and assurance for e-signature processes requiring signer authentication, documented consent flows, tamper-evident auditing and more.”

“With the ability to support 21 CFR Part 11 compliance, life sciences customers at Box can make strides forward in their digital transformation journey,” said Manu Vohra, Managing Director of Life Sciences at Box. “Box GxP Validation now enable customers globally to support paperless trials, regulatory approvals and inspection readiness programs with full confidence in the electronically signed and approved content.”

Box can already be configured to support 21 CFR Part 11 compliance for electronic records by enabling a combination of data management and security features. The introduction of support for 21 CFR Part 11 compliance for electronic signatures with Box Sign enables customers to take a comprehensive approach to the specific needs of the life sciences organizations sector. This covers key R&D processes in clinical, regulatory and safety requiring regulated approvals, as well as helps digitize manufacturing programs with electronic approvals on safety inspections, training records and incident reports.

“Ensuring 21 CFR Part 11 compliance is a critical requirement for the life sciences industry. As the industry strives to drive intelligent automation across the value chain, it is essential to build 21 CFR Part 11 compliant signature-based workflows to integrate compliance within the process,” says Dr. Nimita Limaye, Research VP, Life Science R&D Strategy and Technology, IDC.

Support for Part 11 e-signatures in Box Sign allows organizations to configure compliant signature-based workflows natively within the Box Content Cloud without the need for expensive standalone modules and signer authentication add-ons from e-signature vendors. Admins can empower their teams to automate the entire e-signature workflow, including enacting signer authentication, requiring a signing reason, and enabling immutable audit logs, by simply selecting which users or user groups require support for Part 11 compliance.

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Key benefits of Part 11 support in Box Sign, include:

• Unlimited Part 11 e-signatures: With unlimited e-signatures at no additional cost natively in the Box Content Cloud, customers can leverage Box Sign for all their research, development, and manufacturing processes, without worrying about incremental costs.
• Automated Part 11 Workflow: The 21 CFR Part 11 workflow in Box Sign automates the entire process for both senders and signers, ensuring a seamless and simple e-signature experience, specifically tailored to meet 21 CFR Part 11 compliance requirements without the need to manually configure signer authentication, signing reasons, and more.
• Simplified Compliance: Box Sign Part 11 streamlines compliance by providing a user-friendly interface for senders, signers, and admins. Because content is stored centrally within Box, users can avoid duplicate and outdated versions across multiple systems, making compliance effortless.
• Cost-Efficient Solution: By eliminating the dependence on expensive third-party signer authentication transactions or standalone deployment modules, Box Sign Part 11 offers a cost-efficient solution for organizations seeking compliance with 21 CFR Part 11 regulations.
• Precise Admin Controls: Admins have granular control over 21 CFR Part 11 workflow settings within Box Sign. This enables admins to selectively grant access to specific users or groups, ensuring that the compliance process is tailored to the unique needs and structure of the organization.

“Enabling Part 11 compliance for Box Sign has been our top priority to support our regulated life sciences customers’ FDA-regulated processes,” said Tom Cowles, Chief Compliance Officer at Box. “Box Sign Part 11 gives teams complete control, visibility and assurance for e-signature processes requiring signer authentication, documented consent flows, tamper-evident auditing and more.”

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