Accelerated FDA Compliance with Arena Validate
Arena Validate is a cloud software solution meticulously designed to expedite FDA 21 CFR Part 820 and Part 11 compliance processes. By leveraging Arena's complete validation package, your teams can significantly reduce the time spent on validating Arena's application. This comprehensive validation package encompasses essential elements like change and document management, design controls, electronic records, electronic signatures, and quality management.
Benefits of Arena Validate
Arena Validate empowers your organization to focus on core competencies by streamlining the validation process. It allows QA and Regulatory Affairs teams to tap into Arena's validated methodology and expertise. Validation teams can benefit from reduced validation burdens and avoid intensive system-level tests common in on-premises applications. Executive stakeholders can have peace of mind knowing all necessary documentation is in place for Arena's validation.
Facilitating Cross-Functional Success
The beauty of Arena Validate lies in its ability to facilitate cross-functional collaboration. Product development teams can always access the latest Arena software releases and enhancements, while quality teams receive faster validation results to meet compliance requirements. Moreover, cross-functional teams can seamlessly embrace software enhancements through SaaS updates, ensuring smoother validation processes.
Seamless Upgrade Process with Arena Validate
Traditional on-premises software solutions often face challenges when it comes to validating upgrades, deterring customers from embracing the latest releases. Arena Validate eliminates the fear of upgrading by handling the heavy lifting for every Arena PLM and QMS release or enhancement. This ensures accelerated development and execution, simplifies impact assessment, and minimizes disruptive validation efforts, allowing your organization to deliver safe, compliant devices efficiently.
Testimonial from a Satisfied Customer
According to Ed Reith, Supply Chain Engineering Manager at Ebb Therapeutics, Arena's implementation was seamless with complete IQ and OQ documents provided. The standard out-of-the-box functionality reduced the scope of work, resulting in a productive PQ process with minimal oversight. This testimonial highlights the effectiveness and efficiency of Arena Validate in driving successful compliance outcomes.