Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
itemis ANALYZE serves as a sophisticated solution for managing traceability, effectively constructing a detailed knowledge graph that links every aspect of your development toolchain, from modeling tools to code. It integrates effortlessly into existing workflows, enhancing productivity while offering a thorough overview of the complete project lifecycle. Designed to complement ALM, PLM, or Requirements Management Tools, it ensures transparency and meticulous documentation throughout the development process, making it easy to validate that all requirements are met to uphold quality standards. You can easily identify and monitor the connections among various components of a software system, such as requirements, design, code, and testing, while also addressing the security risks that may arise. The platform includes built-in validations to maintain the integrity of your traceability efforts, with automatic detection of duplicate entries. Additionally, itemis ANALYZE is equipped with a wide range of specialized tool adapters, as well as generic adapters for commonly used file formats, ensuring versatility and ease of integration in diverse project environments. This comprehensive approach ultimately allows teams to focus more on development and less on administrative overhead.
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
No
API Access
Has API
Yes
Integrations
Apache Subversion
No
Azure DevOps Server
No
GitHub
No
GitLab
No
Jira Align
No
Redmine
No
Integrations
Apache Subversion
Yes
Azure DevOps Server
Yes
GitHub
Yes
GitLab
Yes
Jira Align
Yes
Redmine
Yes
Pricing Details
$1000 one-time payment
Free Trial
Yes
Free Version
No
Pricing Details
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial
Yes
Free Version
No
Deployment
Web-Based
No
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
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
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
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Itemis
Founded
2003
Country
Germany
Website
www.itemis.com/en/yakindu/traceability/
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product Features
Project Management
Agile Methodologies
Yes
Budget Management
No
Client Portal
Yes
Collaboration Tools
No
Cost-to-Completion Tracking
Yes
Customizable Templates
Yes
Gantt Charts
Yes
Idea Management
Yes
Kanban Board
Yes
Milestone Tracking
No
Portfolio Management
No
Resource Management
No
Time & Expense Tracking
No
Traditional Methodologies
Yes
Product Features
Application Lifecycle Management
Administrator Level Control
Yes
Defect Tracking
Yes
Iteration Planning
No
Project Management
No
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
Yes
Automated Test Generation
Yes
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes