
Cloud-native quality management connected to your product record
Arena QMS, a PTC business, is a product-centric, cloud-native quality management system that connects quality processes with the product record in a single, secure platform. It helps regulated manufacturers manage closed-loop quality processes—CAPAs, nonconformances, training, device master records (DMRs), and design history files (DHFs)—to simplify compliance with standards like FDA 21 CFR Part 11, ISO 13485, and ISO 9001.
Document and track CAPAs, nonconformances, and corrective actions linked directly to the affected product records.
Control quality documents, DMRs, and DHFs with revision history, approvals, and full audit traceability.
Assign, track, and verify employee training and certifications to keep teams compliant company-wide.
Built-in support for FDA 21 CFR Part 11, ISO 13485, ISO 9001, and other quality and design control standards.
Collaborate securely with suppliers and partners on quality processes and supply chain quality issues.
Connects quality directly to bill of materials, change orders, and the product lifecycle in one cloud system.
Dashboards and analytics surface quality metrics, audit readiness, and process bottlenecks in real time.
Manage DMRs, DHFs, and design controls to reach FDA 510(k) clearance and maintain ISO 13485 compliance.
Run closed-loop corrective and preventive action processes tied to the affected parts and products.
Share quality processes securely with suppliers and partners across a multi-tier supply chain.
Unify product development and quality management so engineering changes and quality events stay in sync.
Context-aware AI assistant delivers PLM and QMS best practices and automates workflows across the platform.

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