Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools.
The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities.
Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.
API Access
Has API
API Access
Has API
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
€1300 per year
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
Kovair Software
Founded
2000
Country
United States
Website
www.kovair.com/plm-alm-center-of-excellence/
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
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
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
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