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For highly regulated companies with dispersed teams, it’s difficult to design and deliver high-quality products on time.
You must be able to comply with ISO standards, FDA regulations, and more to drive commercialization success.
Without a single source of truth, it’s difficult to keep everyone on the same page. To meet these demands and drive continuous improvement—you need to manage quality and product records in one place.
Arena Quality Management System (QMS) software connects quality records directly to the product design in a single system. We help you document and track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and corrective and preventive actions (CAPAs) in context to the entire product record and bill of materials (BOM).
Watch our 2-minute Arena Quality Management System video.
Managing disconnected quality and product systems creates confusion and delays commercialization efforts. With Arena’s product-centric QMS software, everyone can stay on the same page throughout the new product development and new product introduction process.
You need to get products designed and developed quickly to capture market share. Arena’s cloud-based quality management system software speeds product launches while ensuring regulatory compliance with the lowest total cost of ownership (TCO).
Arena’s multi-tenant platform is designed to maximize performance, reduce cost, and automate recovery while allowing us to deliver regular enhancements to ensure maximum usability and scalability.
We provide a modern cloud experience, designed to simplify collaboration between you and your partners. You and your partners have controlled, role-based access anytime and anywhere.
Our configurable solutions and proven, best-practice implementation methodology eliminate risky science projects and costly coding to provide the lowest TCO.
Arena QMS brings quality and related product development teams together to speed commercialization efforts, simplify regulatory compliance, and drive continuous improvement.
Arena Solutions helps everyone work together and provides significant value for these teams:
Arena QMS streamlines product realization processes by connecting quality and product records. Our product-centric quality management system improves control of SOPs, DMRs, DHFs, BOMs, documents, training records, and more to simplify compliance.
Learn more about Arena’s product-centric QMS solution.
The burden to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens these leaders face. For medical device companies, document control is critical to success. Despite that absolute, traditional stand-alone QMS systems address only a subset of what’s needed.
Read the “7 Principles of Product-Centric Quality Management” ebook to learn how connected quality and product processes are better.
If you design complex medical devices, you need to manage the full development process while meeting FDA and ISO regulatory standards. Learn how Arena’s enterprise QMS platform addresses medical device and biotechnology industry challenges.
