Audience
Created for medical device manufacturers developing complex products.
About Arena QMS
Arena’s product-centric quality management system (QMS) software enables medical device manufacturers to deliver safe and compliant products to market fast. Arena QMS streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena QMS ensures regulatory compliance to various quality standards and regulations, including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans.
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Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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Integrations
Company Information
Arena, a PTC Business
Founded: 2000
United States
www.arenasolutions.com/platform/qms/
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Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
Webinars
In Person
Videos
Support
Phone Support
Online
Arena QMS Frequently Asked Questions
Arena QMS Product Features
Quality Management
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Defect Tracking
Not Supported
Maintenance Management
Not Supported