Jama Software Enhancements Improve Auditability and E-signature Management for FDA 21 CFR Part 11 and Streamline Workflows

Today, Jama Software, the leading development platform provider for building complex products and integrated systems, announced a series of updates for the Jama Connect™ Review Center. The additions to Review Center, a favorite feature among Jama Connect customers, include improved review creation, a simplified review process, and updates to electronic signatures in reviews which address regulations like FDA 21 CFR Part 11 for medical device developers.

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“For too many development teams, traditional product review processes stifle collaboration and slow time to market,” said Jama Software CEO, Scott Roth.

Scott added, “Our latest Review Center enhancements introduce a more unified and streamlined approach by reducing time spent on manual processes and in arduous meetings. This helps our customers bring new products to market quicker than their competition and validates our commitment to providing the best possible experience for development teams using Jama Connect.”

Jama Connect Review Center offers an iterative, collaborative approach to reviewing requirements and tests in real-time. It simplifies the review and approval process by giving unlimited stakeholders easy access to provide feedback where required, resulting in quicker response times and faster review cycles.

The updated Review Center feature presents Jama Software customers with two major improvements:

Enhanced workflows to streamline the review setup process

Customers will now experience a more consistent way to meet review objectives with updated workflows and a simplified application, management, and accessibility of electronic signatures. These updates allow for an easier path to regulatory compliance for all Jama Connect users.

Adherence to e-signature requirements of FDA 21 CFR Part 11

Jama Software customers in the medical device industry will benefit from Review Center’s adherence with 21 CFR Part 11 compliance requirements, as it enables easier configuration of review settings for electronic signatures to ensure they can be properly referenced and signed off on across different teams. These upgrades also benefit a broader array of regulated customers looking to use Review Center as a compliant system of record.

With more than 600 customers worldwide, the new Review Center improvements reinforce Jama Software’s commitment to maintaining an ongoing partnership with existing users and enhancing the overall product development experience.

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