Box Sign Achieves Support for FDA 21 CFR Part 11 Compliance to Streamline Regulated E-signature Workflows

Box, Inc, the leading Content Cloud, 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.”

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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.

SOURCE: Businesswire