Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
GlobalVision stands out as the premier review software tailored for regulated sectors. Quickly identify significant errors and accelerate your market entry while maintaining high standards of quality. Enhance the efficiency and precision of your quality assurance procedures by validating content throughout every stage of your workflow. Detect discrepancies immediately by isolating even the most minute differences between documents. Expedite the approval process by minimizing review durations, thereby preventing unwarranted holdups between teams. Guarantee that all replicated documents are precise for both internal assessments and regulatory submissions. Additionally, confirm that no new issues arise during the evolution of your content, ensuring a seamless development process. This comprehensive approach not only safeguards quality but also streamlines operations across various departments.
API Access
Has API
No
API Access
Has API
No
Integrations
Rimsys
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$395 per user per month
Free Trial
Yes
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
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
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
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Arena, a PTC Business
Founded
2000
Country
United States
Website
www.arenasolutions.com/platform/qms/
Vendor Details
Company Name
Global Vision
Founded
1990
Country
Canada
Website
www.globalvisioninc.com
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
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
No
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
Yes
Training Management
No