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Average Ratings 387 Ratings

Total
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features
design
support

Average Ratings 0 Ratings

Total
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features
design
support

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Description

Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.

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 

Screenshots View All

Screenshots View All

Integrations

Azure DevOps Server Yes 
GitHub Yes 
AWARD Yes 
Apache Subversion No 
Epsilon3 Yes 
GitLab No 
Kivo Yes 
LDRA Tool Suite Yes 
Modern Requirements4DevOps Yes 
OpsHub Yes 
Planview Hub Yes 
Planview Viz Yes 
Rally Software Yes 
Rapita Verification Suite Yes 
Redmine No 
TestRail Yes 
Trace.Space Yes 
VectorCAST Yes 
Zoho Directory Yes 
qTest Yes 

Integrations

Azure DevOps Server Yes 
GitHub Yes 
AWARD No 
Apache Subversion Yes 
Epsilon3 No 
GitLab Yes 
Kivo No 
LDRA Tool Suite No 
Modern Requirements4DevOps No 
OpsHub No 
Planview Hub No 
Planview Viz No 
Rally Software No 
Rapita Verification Suite No 
Redmine Yes 
TestRail No 
Trace.Space No 
VectorCAST No 
Zoho Directory No 
qTest No 

Pricing Details

No price information available.
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 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) Yes 
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

Jama Software

Founded

2006

Country

United States

Website

www.jamasoftware.com/faster-requirements-management

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Application Development

Access Controls/Permissions Yes 
Code Assistance No 
Code Refactoring No 
Collaboration Tools Yes 
Compatibility Testing No 
Data Modeling No 
Debugging No 
Deployment Management Yes 
Graphical User Interface No 
Mobile Development No 
No-Code No 
Reporting/Analytics Yes 
Software Development Yes 
Source Control No 
Testing Management No 
Version Control No 
Web App Development No 

Application Lifecycle Management

Administrator Level Control Yes 
Defect Tracking Yes 
Iteration Planning Yes 
Project Management Yes 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Product Lifecycle Management

Change Management Yes 
Compliance Management Yes 
Cost Tracking No 
Design Management No 
Document Management Yes 
Product Data Management Yes 
Project Management Yes 
Requirements Management Yes 
Supplier Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
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 

Test Management

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