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What is TraxQM?

TraxQM is a quality management system focused on risk, designed to support organizations in meeting regulatory requirements, improving quality workflows, and enhancing operational efficiency through a centralized, AI-powered platform. This innovative system enables businesses to take a proactive approach to compliance by digitalizing their processes and establishing structured methodologies that align with international standards such as ISO and GxP. With crucial modules for document management, risk assessment, oversight of Corrective and Preventive Actions (CAPA), change control implementation, audit execution, and training facilitation, TraxQM allows teams to manage every aspect of quality operations within one cohesive system. It ensures data integrity through features like automated version control, comprehensive audit trails, and compliant electronic signatures, which help maintain traceability and meet regulatory requirements. Additionally, TraxQM harnesses the power of artificial intelligence to enhance decision-making by analyzing risks, suggesting specific control actions, and identifying relevant Key Performance Indicators (KPIs) that align with the organization’s strategic objectives, thereby improving overall quality management capabilities. This robust QMS not only simplifies workflows but also encourages teams to cultivate a culture of ongoing improvement in their quality initiatives. Organizations that adopt TraxQM can expect to see significant advancements in their compliance and quality management practices.

What is Orcanos?

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

Media

Media

Integrations Supported

Microsoft 365
Docusign

Integrations Supported

Microsoft 365
Jira
Salesforce

API Availability

API Availability

Pricing Information

$403.97 per month

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

TraxQM

Company Location

United States

Company Website

www.traxqm.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Categories and 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

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

Document Control

Not specified

Quality Management

Not specified

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Not specified

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