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
Effective collaboration across multiple functions, disparate enterprise tools, multidisciplinary data, and stakeholders is key to developing smart products simultaneously. Connect through an interoperable digital enterprise portal to create smart products! Secure integration platform connecting complex tools data for developing competitive products. To collaborate, exchange product development data across multiple enterprise tools. To conduct digital design reviews with stakeholders. For a closed loop process, manage changes, revisions, and releases! To manage Bill of Materials (BOM), across the digital thread. To handle multiple product Variant Configurations. To allow dynamic end-to-end traceability of product development artifacts, which aids regulatory compliance.
API Access
Has API
API Access
Has API
Integrations
Rimsys
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Arena, a PTC Business
Founded
2000
Country
United States
Website
www.arenasolutions.com/platform/qms/
Vendor Details
Company Name
Kovair Software
Founded
2000
Country
United States
Website
www.kovair.com/plm-alm-center-of-excellence/
Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Product Features
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Product Lifecycle Management
Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier Management
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes