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QT9 QMS

Pre-Validated QMS Software by QT9 Software

QT9 QMS by QT9 Software helps teams centralize quality processes on a platform that scales with your business. Streamline audits, training and document control — implemented in under 30 days.

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25+ QMS modules for complete quality management

Proven eQMS for life sciences companies

QT9 makes it easy for life sciences companies to get to market faster. Achieve traceability with a pre-validated platform.  

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Drive quality performance across your organization

QT9 QMS enables real-time access to quality data, streamlines team communication, and automates alerts to ensure faster, smarter decisions.

Connect quality and people

Centralize quality data, information and processes in one system for easy accessibility wherever employees are located.

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Drive customer satisfaction

Embed quality into daily workflows to help ensure products and services meet or exceed customer requirements and expectations.

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Provide better solutions

Invest in continuous improvement by providing a scalable, fully-automated quality system that boosts accuracy and efficiency.

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Optimize productivity

Accelerate productivity and get products to market faster by streamlining quality and compliance. Dynamically populated data and automated workflows help keep projects on track.

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Adapt and innovate

Get the tools you need to stay agile and more easily respond to changing regulatory and market demands. Let QT9 handle the busy work, while your team focuses on innovation.

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QT9 QMS software by QT9 Software
Quality Management Software
Centralize quality management in one platform.
1,000+ Customers

An award-winning platform. Loved by customers.

QT9 QMS is a leader in Quality Management Software on G2 — the largest software marketplace.

82%+ of compliance leaders cite third-party risks as material issues — making integrated compliance tools not just useful, but essential.

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QMS solutions for any industry. Increase productivity.

QT9 QMS software interface by QT9 Software

Get QT9 QMS in the cloud or on premise

Flexible deployment to match your IT strategy without compromising security or speed.

 

QT9 QMS next-generation automation

Get benefits beyond everyday automations with embedded workflows that enable you to work smarter and faster. Eliminate time-consuming manual quality checks and gain real-time insights to reduce human errors and speed decision-making. 

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QT9 QMS is pre-validated

QT9 QMS provides a pre-validated environment, enabling faster implementation and return on investment. Every module and global feature goes through a step-by-step validation. What's more, you don't have to invest in it yourself. 

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Provide accurate audit trails for inspections

QT9 QMS provides timeline traceability that gives transparency into every action. This makes it easier to identify defects or trace defective batches for targeted recalls.

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Employee, customer and supplier portals 

QT9 QMS customer, supplier and employee web portals ensure secure access to vital documents, improving communication and collaboration.

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Faster issue detection and resolution

QT9 QMS enables you to identify quality issues as they occur, so you can take immediate corrective actions to minimize impact. This prevents defects, reduces downtime and minimizes compliance risks.

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Reduce the learning curve

From startups to enterprises, get up to speed with a platform that’s quick to learn and easy to love. QT9 QMS helps teams minimize mistakes in data entry and workflows, ensuring accurate documentation, seamless audits and compliance with industry standards.

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Hosted in U.S. & Europe — GDPR-Compliant Infrastructure

Pre-Validated QMS for ISO, FDA, EU MDR & AS9100

Simplified international medical device quality compliance.

Quality management solutions for every stage of the medical device lifecycle.
 
 
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EU MDR Compliance, Simplified

QT9 QMS comes fully pre-validated to help medical device and life sciences companies meet EU MDR requirements with built-in traceability, risk management and audit-ready records. Hosted in the EU for local data residency and regulatory compliance.
 
 
EU MDR Compliance

 

Built-in electronic documentation compliance with full traceability

A pre-validated system with automatic audit trail, e-signatures and everything you need for FDA compliance.
 
 

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End-to-end U.S. pharmaceutical compliance

Electronic Batch Records to facilities maintenance - a quality system built for Pharma.
 
 
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Simplified compliance for medical devices in the U.S.

Risk management to product design controls, a total quality management solution for the medical device industry.
 
 
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A one-stop solution for meeting ISO 9001 requirements

More than 25 standard modules, including document control, risk management, management review and CAPA management.
 
 
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A streamlined environmental management system

Easily assess and document risks and opportunities, track progress and correct course when needed.
 
 
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Streamline and standardize testing lab compliance.

Easily manage lab requirements, including structural, resource, process and management systems.
 
 
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Accurate and efficient aerospace and defense compliance

Meet industry-specific compliance requirements with an easy-to-use platform.
 
 
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Centralize and simplify automotive IATF 16949 compliance

Ensure consistent quality, prevent defects, improve safety and reduce waste.
 
 
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Meet food safety regulations with accuracy and efficiency

Centralize, collaborate and integrate for end-to-end food quality and safety compliance.
 
 
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Food safety compliance throughout the supply chain

Extensive document control and audit management for better SQF compliance.
 
 
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QMS features that give your team a competitive edge

Expand QT9 QMS with built-in modules designed to fit your unique workflows.

Centralize Documents

Access documents in one place for better document management. 

Centralize Documents

Approve CAPAs

Automate your CAPA processes and track corrective actions in real-time.

Approve CAPAs

Streamline Audits

Track and manage scheduling details and the results of your audits.

Streamline Audits

Monitor Deviations

Easily track your temporary deviations with email alerts and to-do lists.

Monitor Deviations

Minimize Risk

Manage risk analysis by assigning risk score, tasks, priorities, approvals, etc.

Minimize Risk

Reduce Complaints

Track customer feedback and alert responsible parties.

Reduce Complaints

Modernize Inspections

Capture inspection details online and link related documents for reference.

Modernize Inspections

Track Engineering Changes

Control ECR/ECN by assigning tasks, email alerts and electronic approvals.  

Track Engineering Changes

Train Employees

Manage training online for employees and job roles with personalized tests. 

Train Employees
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Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

Why choose a pre-validated QMS?
In FY 2023, ~80% of inspected firms received FDA 483 observations — underscoring the critical need for robust compliance systems

  • FDA and ISO compliance out-of-the-box

  • Rapid cloud deployment for faster implementation

  • Audit-ready with timeline traceability 

  • Electronic signature approvals and secure access controls

  • Continuous validation and updates

What compliance standards need validation?

• ISO 13585
• ISO 9001
• ISO 14001
• ISO 17025
• AS9100
• MoCRA

• FDA 21 CFR Part 11
• FDA 21 CFR Part 210/211
• FDA 21 CFR Part 820
• EU GMP
• EU MDR
• GxP Compliance
Is IQ, OQ, PQ part of validation?

QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

How does pre-validated QMS software save money?

  • Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.

  • Reduces downtime waiting for your QMS to be approved for use.

  • Minimizes the risk of any failed audits due to flawed validation protocols.

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Why Teams Choose QT9 QMS Software

No hidden fees. No user limits. No compromises. See how QT9 QMS by QT9 Software compares to traditional quality management software.

Features
QT9 QMS Software
Traditional QMS
Pricing Model
✓ Concurrent License (No per-user fees)
✗ Per-user licensing (Costs increase with growth)
Modules Included
✓ 28+ Modules (All included, no add-ons)
✗ Limited base modules (Extra fees for add-ons)
Portal Access
✓ Unlimited & Free (Customer, Supplier, Employee)
✗ Limited or paid portals (Additional licensing required)
Annual Training Fees
✓ $0 (Unlimited training & support)
✗ 15-20% annually (Plus support contracts)
File Storage
✓ Unlimited (150MB per file limit)
✗ Storage limits (Extra fees for more space)
Multi-Site Support
✓
✗
Pre-Validated System
✓
✗
21 CFR Part 11 Compliant
✓
Varies

21 CFR Part 11 Compliant

Built-in electronic signature and audit trail compliance for FDA-regulated industries.

QT9 University

Online, on-demand training resources and community forum for continuous learning.

Ready to see the QT9 difference?

Join 1,100+ companies worldwide who trust QT9 QMS software for their quality management.

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1,000+ of the world's leading companies trust QT9

Celebrated by Experts. Loved by Customers.

QT9 QMS is a leader in Quality Management Software on Capterra, Software Advice and GetApp.

See what quality leaders say about QT9 QMS

“I love that QT9 is an all-encompassing suite of modules that covers every part of my QMS. We maintain an ISO9001:2015 certification, and this program will take the place of countless spreadsheets and emails.”
Sara Cutigni
APR Allen Plastics
“Easy to use and helps to organize information across our company. I like that you can easily load in tasks and reminders. Also, you can see who in the group still needs to complete something.”
Bill Ranous
Fulton
“QT9 QMS Software is a gamechanger for my organization. Implementation of the software was easy and quick. The customer support was unmatched. ”
Tara Buchanan
Torrent Photonics

Quality management resources

Integrated QMS, ERP & MRP for 2026 Manufacturing
Group of professionals around computer screen in factory discuss QMS, ERP, MRP software integration
QT9 ERP

Integrated QMS, ERP & MRP for 2026 Manufacturing

October 16, 2025 6 min read
QT9 Earns G2 and Capterra Fall 2025 Awards
QT9 QMS G2 Fall Awards Badges including Easiest to Use and Best Support
Company News

QT9 Earns G2 and Capterra Fall 2025 Awards

October 09, 2025 5 min read
Pharma Data Integrity Updates: EU GMP Chapter 4
Scientists maintaining pharmaceutical data integrity in compliance with EU GMP Chapter 4
Pharma

Pharma Data Integrity Updates: EU GMP Chapter 4

September 18, 2025 8 min read

Try QT9 for free

Ready to simplify your quality processes? No credit card needed.

Schedule Demo

See a personalized demo of  QT9 QMS with our sales team.

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Explore how easy QT9 QMS is able to connect operations.

Get a Quote

  See how much QT9’s all-in-one platform costs. 

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Available M-F 8 AM to 5 PM CT. Speak to a QT9 expert.