Simplify FDA Compliance with Arena Solutions PLM Validation

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Simplify FDA Compliance with Arena Solutions PLM Validation

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.

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Empowering Aerospace and Defense Manufacturers with Secure Compliance Solutions

Secure Compliance in the Cloud

Manufacturers in the aerospace and defense industry face strict regulatory requirements such as International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR) governing the export of sensitive products and technical data. Additionally, regulations like the Cybersecurity Maturity Model Certification (CMMC), Defense Federal Acquisition Regulation Supplement (DFARS), and National Institute of Standards and Technology (NIST) mandate the implementation of robust security measures. To address these challenges, Arena Solutions PLM for AWS GovCloud offers a secure, turnkey solution that helps companies achieve export controls and cybersecurity compliance while accelerating new product development.

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Revolutionizing Product Lifecycle Management with Arena Solutions PLM

Green PLM Conference - Berlin, Germany 2024

Arena Solutions PLM is proud to be a Gold Sponsor at the upcoming Green PLM Conference in Berlin, Germany, on November 14, 2024. This industry event is dedicated to sustainability and environmentally conscious product lifecycle management. Professionals from high-tech, manufacturing, and consumer goods sectors will gather to explore innovative solutions and best practices in green PLM. Attendees can expect insightful sessions, networking opportunities, and engaging discussions on driving sustainability in product development.

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Enhancing Product Development Efficiency with Arena Solutions Engineering Change Management

Automated Change Processes for Streamlined Product Launches

Arena Solutions PLM offers an Engineering Change Management solution that plays a key role in their product lifecycle management (PLM) and quality management system (QMS) offerings. This solution enables internal teams and supply chain partners to efficiently review and collaborate on formal engineering change requests (ECR) and engineering change order (ECO) processes with automated approvals. By utilizing no-code automations, subsequent engineering change and quality processes are initiated seamlessly, enhancing the overall efficiency of product development and launch timelines. With Arena, the creation, sharing, review, and release of product design changes are facilitated, helping to reduce review cycles and accelerate time to market.

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Arena Solutions PLM: Driving Innovation and Continuous Improvement in Engineering Design Efficiency

Empowering Innovation in Medical Device Development

In the realm of medical device development, engineering teams face numerous challenges in ensuring timely and efficient product design. The convergence of electrical, mechanical, and software design components necessitates a cohesive approach to guarantee interoperability throughout the development process. Arena Solutions PLM offers a comprehensive Quality Management System (QMS) software solution that centralizes the entire product record and links it to pertinent quality records. By adopting a product-centric QMS strategy, all essential elements such as items, bills of materials (BOMs), approved manufacturers (AML), and related documents are meticulously controlled within a unified platform.

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Enhancing Product Development with Arena Solutions PLM

Streamlining Product Development Processes

Arena Solutions PLM is a powerful platform designed to help businesses streamline their product development processes. By utilizing Arena's PLM solutions, companies can accelerate new product development, reduce time-to-market, and ultimately deliver high-quality products to their customers. With features that enable collaboration, version control, and real-time visibility into project status, Arena Solutions PLM empowers teams to work efficiently and effectively.

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