Quality Management System

Product-Centric QMS Speeds Commercialization

The Challenge to Get Safe Products to Market

Global Compliance Regulations

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.

HOW WE HELP

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).

Produces Safe, HIgh-Quality Products

  • Simplifies compliance, improves design control, and reduces your audit risks
  • Fosters continuous improvement with traceable quality processes
  • Enhances visibility and traceability by managing quality processes throughout the entire product lifecycle

Creates a Single System of Truth

  • Leverages a single quality management system connected to the product design
  • Manages critical documents for training, SOPs, DMRs, DHFs, and CAPAs
  • Leverages closed-loop quality processes to speed resolution of issues

Drives Compliant Development Processes

  • Avoids confusion throughout new product development and introduction
  • Ensures employees and partners are trained with proven competence
  • Unifies your quality management process to reduce FDA and ISO compliance risks

Watch our 2-minute Arena Quality Management System video.

Why Product-Centric
QMS is Better

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.

WHY ARENA’S CLOUD PLATFORM IS BETTER

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).

Ensures Compliance

Scalable

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.

Collaborative

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.

Advances Quality
Affordable Dollar QMS

Affordable

Our configurable solutions and proven, best-practice implementation methodology eliminate risky science projects and costly coding to provide the lowest TCO.

HOW ARENA QMS MEETS YOUR TEAM GOALS

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:

ENSURE COMPLIANCE AND EXCEED QUALITY GOALS

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.

WHY YOU NEED A ROCK-SOLID APPROACH TO QUALITY MANAGEMENT

Quality Manager Eyes

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.

INDUSTRIES WE SERVE

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.

Leading Innovators Rely on Arena QMS

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What our customers are saying on Trust Radius

SEE ARENA QMS
IN ACTION