Box Sign Achieves Support for FDA 21 CFR Part 11 Compliance to Streamline Regulated E-signature Workflows
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The announcement that Box Sign now supports FDA 21 CFR Part 11 compliance for electronic signatures signifies a significant development for Box, Inc. in the healthcare and life sciences sectors. FDA 21 CFR Part 11 sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records. This regulation is crucial for companies in the life sciences industry that are required to maintain rigorous documentation for FDA regulatory purposes.
By integrating Part 11 compliant e-signatures into their Content Cloud, Box is addressing a critical pain point for life sciences organizations. The ability to automate and digitize processes such as clinical trials, regulatory filings and safety inspections while ensuring compliance is a considerable advantage. It allows these companies to streamline operations, reduce the risk of non-compliance and potentially accelerate the time to market for new drugs and therapies. However, organizations must still ensure that their use of Box Sign's capabilities aligns with all other aspects of Part 11, including system validation, audit trails, record retention and documentation practices to fully comply with the regulation.
From a research and development perspective, the digitization of signature-based workflows is a transformative step for life sciences companies. The transition to paperless systems facilitates better data management, increases efficiency and enhances the integrity of clinical trials and other R&D processes. As Box Sign offers unlimited Part 11 e-signatures within its Content Cloud, it potentially reduces overhead costs associated with document management and compliance.
However, stakeholders should be aware that while Box Sign's new feature is a tool to support compliance, the responsibility for maintaining a compliant environment still rests with the organization. Users must ensure that the configuration and application of Box Sign's capabilities are done in a manner that meets all regulatory requirements. Additionally, there may be challenges in training personnel to properly use these new digital tools and in integrating them into existing workflows without disrupting ongoing operations.
Box's strategic move to enhance its offerings for the life sciences sector by adding FDA 21 CFR Part 11 compliant e-signatures could positively impact its market positioning. As the life sciences industry continues to grow, with increased emphasis on digital transformation, Box is positioning itself as a key player in this space by providing a solution that addresses industry-specific needs. This could lead to increased adoption of Box's services within the life sciences sector, potentially driving revenue growth and improving its competitive edge.
The long-term implications for Box could include deeper penetration into the life sciences market and potential expansion into other heavily regulated industries that also require stringent documentation controls. While this development may attract new customers, Box must maintain a high level of service and ensure that its compliance features keep pace with evolving regulations to retain customer trust and loyalty.
"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
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