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Description
Arena PLM helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. Arena enables every participant throughout new product development (NPD) and new product introduction (NPI) to collaborate more effectively while ensuring regulatory compliance with FDA, ISO, ITAR, EAR, and environmental requirements.
Description
Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Rimsys
Yes
1factory Manufacturing Quality
Yes
Allegro X Design Platform
Yes
Cofactr
Yes
Expandable
Yes
FlowEQ
Yes
IdoSell
Yes
Kenandy
Yes
Leverage
Yes
Microsoft Dynamics GP
Yes
Integrations
Rimsys
Yes
1factory Manufacturing Quality
No
Allegro X Design Platform
No
Cofactr
No
Expandable
No
FlowEQ
No
IdoSell
No
Kenandy
No
Leverage
No
Microsoft Dynamics GP
No
Pricing Details
Contact vendor
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Arena by PTC
Founded
2000
Country
United States
Website
www.arenasolutions.com
Vendor Details
Company Name
Arena, a PTC Business
Founded
2000
Country
United States
Website
www.arenasolutions.com/platform/qms/
Product Features
Product Lifecycle Management
Change Management
Yes
Compliance Management
Yes
Cost Tracking
Yes
Design Management
Yes
Document Management
Yes
Product Data Management
Yes
Project Management
Yes
Requirements Management
Yes
Supplier Management
Yes
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes