aligned elements

aligned elements

Aligned AG
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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.

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.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

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

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$403.97 per month
Free Version
Free Trial

Pricing

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

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

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

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

TraxQM
United States
www.traxqm.com

Company Information

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

Alternatives

Alternatives

ReqView

ReqView

Eccam
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Kovair ALM-PLM CoE

Kovair ALM-PLM CoE

Kovair Software
Kovair ALM

Kovair ALM

Kovair Software

Categories

Categories

Application Lifecycle Management Features

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 Features

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

Integrations

Apache Subversion
Azure DevOps Server
Docusign
GitHub
GitLab
Jira Align
Microsoft 365
Redmine

Integrations

Apache Subversion
Azure DevOps Server
Docusign
GitHub
GitLab
Jira Align
Microsoft 365
Redmine
Claim TraxQM and update features and information
Claim TraxQM and update features and information
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