Arena QMSArena, a PTC Business
|
aligned elementsAligned AG
|
|||||
Related Products
|
||||||
About
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.
|
About
Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity.
The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.
Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.
|
|||||
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
|||||
Audience
Created for medical device manufacturers developing complex products.
|
Audience
Medical Device Manufacturers looking for a design control management solution
|
|||||
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Not Supported
|
API
Offers API
Supported
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
|
Pricing
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version
Not Supported
Free Trial
Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
|
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
|
|||||
Company InformationArena, a PTC Business
Founded: 2000
United States
www.arenasolutions.com/platform/qms/
|
Company InformationAligned AG
Founded: 2007
Switzerland
www.aligned.ch/
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
|
|||||
|
|
||||||
|
|
||||||
Categories |
Categories |
|||||
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Not Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
|
Application Lifecycle Management Features
Administrator Level Control
Supported
Defect Tracking
Supported
Iteration Planning
Not Supported
Project Management
Not Supported
Release Management
Supported
Requirements Review
Supported
Task Management
Supported
Test Case Tracking
Supported
User Level Management
Supported
Version Control
Supported
Requirements Management Features
Automated Functional Sizing
Not Supported
Automated Requirements QA
Supported
Automated Test Generation
Supported
Automated Use Case Modeling
Not Supported
Change Management
Supported
Collaboration
Supported
History Tracking
Supported
Prioritization
Supported
Reporting
Supported
Status Reporting
Supported
Status Tracking
Supported
Summary Reports
Supported
Task Management
Supported
To-Do List
Supported
Traceability
Supported
User Defined Attributes
Supported
|
|||||
Integrations
Apache Subversion
Not Supported
Azure DevOps Server
Not Supported
GitHub
Not Supported
GitLab
Not Supported
Jira Align
Not Supported
Redmine
Not Supported
Rimsys
Supported
|
Integrations
Apache Subversion
Supported
Azure DevOps Server
Supported
GitHub
Supported
GitLab
Supported
Jira Align
Supported
Redmine
Supported
Rimsys
Not Supported
|
|||||
|
|
|