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What is aligned elements?

Aligned offers an integrated eQMS and design control for medical device and IVD organizations. The solution is engineered to help companies satisfy international regulatory expectations in a structured and efficient way, without adding unnecessary operational burden. The software aligns with major regulatory frameworks such as ISO 13485, FDA QSMR, EU MDR, and IVDR. It is used by professional teams who need reliable oversight of quality activities, product development, and regulatory documentation throughout the full lifecycle of their products. By uniting electronic quality processes and design control in one system, Aligned enables seamless collaboration across quality assurance, regulatory affairs, research and development, and executive functions. Product requirements, design records, verification and validation evidence, risk management activities, and controlled changes are inherently connected, providing continuous traceability and defensible documentation during audits and inspections.

What is Itemis Analyze?

itemis ANALYZE stands out as an advanced tool for managing traceability, effectively creating a comprehensive knowledge graph that interlinks every element of your development ecosystem, spanning from modeling instruments to actual code. It seamlessly integrates into current workflows, boosting efficiency while providing a complete view of the entire project lifecycle. Tailored to enhance ALM, PLM, or Requirements Management Tools, it guarantees transparency and precise documentation throughout the development journey, making it straightforward to confirm that all criteria are satisfied to maintain quality benchmarks. You can swiftly pinpoint and track the relationships among various elements of a software system, including requirements, design, coding, and testing, while also tackling potential security vulnerabilities. The platform features inherent validations to safeguard the integrity of your traceability initiatives, with automatic identification of duplicate records. Moreover, itemis ANALYZE comes with a broad array of specialized tool adapters, along with generic connectors for frequently utilized file formats, ensuring flexibility and straightforward integration across various project settings. Ultimately, this all-encompassing strategy enables teams to concentrate more on coding and less on bureaucratic tasks, fostering a more innovative and productive development environment. This shift allows for improved collaboration and communication among team members, further enhancing the overall effectiveness of the development process.

Media

Media

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

API Availability

Has API

API Availability

Pricing Information

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Offered?

Pricing Information

$1000 one-time payment
Free Trial Offered?

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

Windows
Mac

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

Itemis

Date Founded

2003

Company Location

Germany

Company Website

www.itemis.com/en/yakindu/traceability/

Categories and Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management

Automated Requirements QA
Automated Test Generation
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Categories and Features

Project Management

Agile Methodologies
Client Portal
Cost-to-Completion Tracking
Customizable Templates
Gantt Charts
Idea Management
Kanban Board
Traditional Methodologies

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