Arena QMS

Connect Quality and Product Processes.

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Overview

Arena QMS is a quality management system that is fully integrated with its Product Lifecycle Management (PLM) solution. This connection provides a single, centralized system for managing both product records and quality processes. It helps medical device, high-tech, and other complex product manufacturers streamline compliance, accelerate product releases, and improve visibility by linking quality events directly to the product design and bill of materials (BOM).

✨ Key Features

  • Integrated with PLM
  • CAPA
  • Document Control (DHF, DMR)
  • Audit Management
  • Training Management
  • Supplier Management
  • Nonconformance (NCMR)
  • Complaint Handling

🎯 Key Differentiators

  • Tight integration between QMS and PLM in a single system
  • Cloud-native, multi-tenant architecture
  • Strong focus on high-tech electronics and medical device industries

Unique Value: Provides a single source of truth for both product and quality information, enabling faster product launches and simplified compliance for complex manufacturers.

🎯 Use Cases (4)

Managing quality processes for medical device development (ISO 13485) Linking CAPAs and complaints directly to the product BOM Controlling the Design History File (DHF) and Device Master Record (DMR) Auditing product development and manufacturing processes

✅ Best For

  • FDA 21 CFR Part 820 and Part 11 compliance
  • ISO 13485 certification for medical devices
  • ISO 9001 compliance

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies that do not need PLM integration
  • Service-based industries
  • Simple manufacturing with no complex product data

🏆 Alternatives

MasterControl Greenlight Guru Propel Oracle Agile

Unlike standalone QMS or PLM systems, Arena offers a connected solution that eliminates the disconnect between product development and quality assurance.

💻 Platforms

Web

🔌 Integrations

Onshape SOLIDWORKS PDM NetSuite SAP Oracle Microsoft Dynamics

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (All tier)

🔒 Compliance & Security

✓ SOC 2 ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ FDA 21 CFR Part 11 ✓ ISO 13485 ✓ ISO 9001 ✓ SOC 2 Type II

💰 Pricing

Contact for pricing
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