Box Sign Achieves Support for FDA 21 CFR Part 11 Compliance to Streamline Regulated E-signature Workflows
16 Januar 2024 - 5:00PM
Business Wire
Box, Inc. (NYSE:BOX), 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.
"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.
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.”
To learn more about achieving 21 CFR Part 11 compliance with the
Content Cloud, visit the Box Blog and join the webinar on January
18th, 2024.
About Box
Box (NYSE:BOX) is the leading Content Cloud, a single platform
that empowers organizations to manage the entire content lifecycle,
work securely from anywhere, and integrate across best-of-breed
apps. Founded in 2005, Box simplifies work for leading global
organizations, including AstraZeneca, JLL, Morgan Stanley, and
Nationwide. Box is headquartered in Redwood City, CA, with offices
across the United States, Europe, and Asia. Visit box.com to learn
more. And visit box.org to learn more about how Box empowers
nonprofits to fulfill their missions.
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Investors: Cynthia Hiponia and Elaine Gaudioso +1 650-209-3463
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