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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Pricing Details

$1000 one-time payment
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

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
Budget Management
Client Portal
Collaboration Tools
Cost-to-Completion Tracking
Customizable Templates
Gantt Charts
Idea Management
Kanban Board
Milestone Tracking
Portfolio Management
Resource Management
Time & Expense Tracking
Traditional Methodologies

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

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