Arena QMS

What is Arena QMS?

Arena's product-centric QMS system connects quality and product processes to simplify regulatory compliance and accelerate product launches. The cloud-based platform provides businesses with tools to build a single source of truth and ensure adherence to quality standards and regulations such as FDA 21 CFR Part 820, Part 11, and ISO 13485 across the entire product lifecycle. Arena QMS links quality records directly to the product design in a unified system, enhancing visibility and traceability by controlling quality processes in context with bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans

Highlights

• Product-centric quality management system that connects quality and product processes
• Cloud-based platform to build a single source of truth for quality and compliance
• Ensures adherence to key quality standards and regulations, including FDA 21 CFR Part 820, Part 11, and ISO 13485
• Links quality records directly to product design in a single, integrated system
• Enhances visibility and traceability by managing quality processes alongside BOMs, SOPs, DMRs, DHFs, specifications, drawings, and training plans