Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

TraxQM is a risk-oriented Quality Management System (QMS) aimed at assisting organizations in navigating regulatory compliance, optimizing quality workflows, and boosting operational effectiveness via a unified, AI-driven platform. This system empowers businesses to adopt a proactive stance toward compliance by digitizing their procedures and implementing structured approaches that comply with global standards like ISO and GxP. Featuring essential modules for managing documents, conducting risk assessments, overseeing Corrective and Preventive Actions (CAPA), implementing change control, executing audits, and facilitating training, TraxQM allows teams to handle the entire spectrum of quality operations within a single system. The platform ensures data integrity through features like automated version control, audit trails, and compliant electronic signatures, which guarantee traceability and adherence to regulatory mandates. Furthermore, TraxQM utilizes artificial intelligence to bolster decision-making by evaluating risks, proposing specific control measures, and recommending pertinent Key Performance Indicators (KPIs) aligned with the organization’s goals, thereby enhancing overall quality management capabilities. Ultimately, this comprehensive QMS not only streamlines processes but also empowers teams to foster a culture of continuous improvement in their quality practices.

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

API Access

Has API

Screenshots View All

Screenshots View All

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

Pricing Details

$403.97 per month
Free Trial
Free Version

Pricing Details

€1300 per year
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

TraxQM

Country

United States

Website

www.traxqm.com

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Application Lifecycle Management

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

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

Alternatives

Alternatives

ReqView Reviews

ReqView

Eccam
SoftExpert EQM Reviews

SoftExpert EQM

SoftExpert
Kovair ALM-PLM CoE Reviews

Kovair ALM-PLM CoE

Kovair Software
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences