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ease
features
design
support

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Write a Review

Description

You can manage your needs, epics and user stories through a series sprints. Each sprint uses your choice of requirements management, model-based systems engineering (MBSE), and test management. You can also choose to use formal change control, configuration management, and change tracking. Cradle®, our requirements management and systems engineering software tool, integrates your entire project lifecycle into one, highly scalable, integrated, multiuser product. Cradle can handle all your requirements management, model driven, defect tracking, and test management needs, no matter how small or large your projects may be. Cradle's unrivaled feature list, flexibility, simplicity, and low cost make it the perfect choice for anyone new to agile methods, systems engineering, or requirements management.

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 Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Apache Subversion No 
Azure DevOps Server No 
GitHub No 
GitLab No 
Jira Align No 
Microsoft Excel Yes 
Microsoft Project Yes 
Microsoft Visio Yes 
Microsoft Word Yes 
Redmine No 

Integrations

Apache Subversion Yes 
Azure DevOps Server Yes 
GitHub Yes 
GitLab Yes 
Jira Align Yes 
Microsoft Excel No 
Microsoft Project No 
Microsoft Visio No 
Microsoft Word No 
Redmine Yes 

Pricing Details

$470.00/one-time/user
RM Desktop - $470
RM Pro - $545
SE Desktop - $625
SE Pro - $700
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 Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux Yes 
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

3SL

Founded

1987

Country

United Kingdom

Website

www.threesl.com

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Application Lifecycle Management

Administrator Level Control No 
Defect Tracking Yes 
Iteration Planning No 
Project Management Yes 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management No 
Version Control Yes 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
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 

Risk Management

Alerts/Notifications Yes 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard Yes 
Exceptions Management No 
IT Risk Management Yes 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

Test Management

Automation Integration Yes 
Collaboration Tools No 
Pass/Fail Results Tabulation Yes 
Reporting / Analytics Yes 
Requirements Management Yes 
Test Scheduling Yes 
Test Tracking Yes 
Time/Budget Tracking No 

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 

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