QT9 QMS

QT9 QMS

QT9 Software
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About

Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.

About

Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling

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

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

Audience

Any organization tracking regulatory compliance (ex: ISO 9001, ISO 13485, AS9100, FDA Compliance, etc.) including Life Sciences, Medical Device, BioMed/Pharma, Aerospace, Food & Beverage and General Manufacturing companies

Audience

Small and growing businesses in Life Sciences & Healthcare

Support

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$10,000/year
Includes all 25+ Modules. Unlimited Training and Support Available. Get a quote today.
Free Version Not Supported
Free Trial Supported

Pricing

Qualio offers transparent, subscription-based pricing that scales with your users and needs. No hidden fees or per-module charges. Growth-stage companies benefit from fast time-to-value and significantly lower total cost of ownership than legacy platforms or consultant-heavy implementations. Contact us for a custom quote.n.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

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

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Reviews/Ratings

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Company Information

QT9 Software
Founded: 2005
United States
qt9software.com/qms

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

Alternatives

Alternatives

Propel

Propel

Propel Software
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Supported
Training Management Supported

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Supported
Device History Supported
Due Date Tracking Supported
Gage Management Supported
Label Printing Supported
Measurement Readings Supported
Multi-Station Management Supported
Out-of-Tolerance Notification Supported
Statistical Data Reporting Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Supported
Audit Trail Supported
Commenting / Notes Supported
Document Check-in / Check-out Supported
For Engineering Documents Supported
Revision History Supported
Version Comparison Supported
Version Rollback Supported

Inspection Features

Appointment Management Supported
Customer Database Supported
Dispatch Management Supported
Equipment Tracking Supported
Photos In Reports Supported
Print on Site Supported
Report Templates Supported
Speech Recognition Not Supported
Subcontractor Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Policy Management Features

Approval Process Control Supported
Attestation Supported
Audit Trails Supported
Policy Creation Supported
Policy Library Supported
Policy Metadata Management Supported
Policy Training Supported
Reporting / Analytics Supported
Version Control Supported
Workflow Management Supported

Integrations

Asana Not Supported
Azure AI Document Intelligence Not Supported
Azure DevOps Not Supported
Dynamics 365 Customer Service Not Supported
GitHub Not Supported
GitHub Advanced Security Not Supported
GitHub Desktop Not Supported
GitLab Not Supported
Google Cloud Operations Suite Not Supported
HubSpot CRM Not Supported
Intercom Not Supported
Jira Not Supported
Microsoft 365 Not Supported
Microsoft Excel Supported
Microsoft OneDrive Not Supported
Microsoft Outlook Supported
RegDesk Not Supported
TestRail Not Supported
Xray Not Supported
Zendesk Not Supported

Integrations

Asana Supported
Azure AI Document Intelligence Supported
Azure DevOps Supported
Dynamics 365 Customer Service Supported
GitHub Supported
GitHub Advanced Security Supported
GitHub Desktop Supported
GitLab Supported
Google Cloud Operations Suite Supported
HubSpot CRM Supported
Intercom Supported
Jira Supported
Microsoft 365 Supported
Microsoft Excel Not Supported
Microsoft OneDrive Supported
Microsoft Outlook Not Supported
RegDesk Supported
TestRail Supported
Xray Supported
Zendesk Supported
Claim QT9 QMS and update features and information
Claim QT9 QMS and update features and information