aligned elements

aligned elements

Aligned AG
TraxQM aligned elements

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TraxQM:

About

TraxQM is a risk-based Quality Management System (QMS) designed to help organizations manage regulatory compliance, streamline quality processes, and improve operational efficiency through a centralized, AI-enhanced platform. It enables companies to take a proactive approach to compliance by digitizing workflows and applying structured methodologies aligned with international standards such as ISO and GxP. It includes core modules for document management, risk analysis, CAPA (Corrective and Preventive Actions), change control, audits, and training, allowing teams to manage the full lifecycle of quality operations in one system. It supports data integrity through automated version control, audit trails, and compliant electronic signatures, ensuring traceability and adherence to regulatory requirements. TraxQM leverages AI to enhance decision-making by analyzing risks, suggesting targeted control measures, and recommending relevant KPIs based on organizational objectives.
aligned elements:

About

Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.
TraxQM:

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
aligned elements:

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
TraxQM:

Audience

Pharmaceutical companies, quality assurance teams, and regulated industries that need to manage compliance, risk, and quality processes through an AI-driven QMS platform
aligned elements:

Audience

Medical Device Manufacturers looking for a design control management solution
TraxQM:

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported
aligned elements:

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported
TraxQM:

API

Offers API Not Supported
aligned elements:

API

Offers API Supported
TraxQM:

Screenshots and Videos

aligned elements:

Screenshots and Videos

TraxQM:

Pricing

$403.97 per month
Free Version Not Supported
Free Trial Not Supported
aligned elements:

Pricing

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial Supported
TraxQM:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
aligned elements:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
TraxQM:

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported
aligned elements:

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported
TraxQM:

Company Information

TraxQM
United States
www.traxqm.com
aligned elements:

Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/
TraxQM:

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TraxQM:

Categories

aligned elements:

Categories

aligned elements:

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Supported
Iteration Planning Not Supported
Project Management Not Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Supported
Automated Test Generation Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported
TraxQM:

Integrations

Apache Subversion Not Supported
Azure DevOps Server Not Supported
Docusign Supported
GitHub Not Supported
GitLab Not Supported
Jira Align Not Supported
Microsoft 365 Supported
Redmine Not Supported
aligned elements:

Integrations

Apache Subversion Supported
Azure DevOps Server Supported
Docusign Not Supported
GitHub Supported
GitLab Supported
Jira Align Supported
Microsoft 365 Not Supported
Redmine Supported
TraxQM:
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