QT9 Software – Integrated QMS & ERP for Regulated Manufacturing
Integrated Quality & Operations Software to Drive Growth
QT9 Software is your all-in-one partner for quality and operations excellence.
QMS Software
All-In-One Quality Management Software
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ERP Software
Unified Enterprise Resource Planning Software
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BI Software
Centralized Business Intelligence Software
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1,200+ Customers
An Award-Winning Platform. Loved by Customers.
Thousands of users rely on QT9’s top-rated software to simplify compliance, reduce manual work and improve operational efficiency. QT9 is recognized on G2 for ease of use, support and rapid ROI.
Unified QMS and ERP Software
QT9 Software integrates Quality Management (QMS) and Enterprise Resource Planning (ERP) to simplify compliance, reduce manual work, and help your operations scale efficiently.
- Centralized Operations
- Proactive Compliance
- Scalable Efficiency
- Digital Traceability
Centralized Operations
How do I connect quality and operations?
QT9 links your ERP and QMS so you can remove duplicate data entry and gain real-time visibility across every department.
Proactive Compliance
How does QT9 improve compliance?
QT9 Software links non-conformances, CAPAs, audits and training records directly to your ERP workflows, helping you catch issues earlier, resolve them faster and maintain compliance while improving supplier and equipment performance.
Scalable Efficiency
How do I improve compliance without slowing down operations?
Automate documentation, streamline audits, and enhance traceability across your organization with QT9 Software. Our connected platform helps reduce delays, enforce compliance, and improve responsiveness, supporting enterprise-wide efficiency and scalable operations.
Digital Traceability
How can I save time managing electronic batch records and design history files
With QT9 Software’s integrated ERP and QMS, Electronic Batch Records (EBRs) and Design History Files (DHF) are captured and maintained automatically in real time. Ensure regulatory compliance, reduce risk and gain instant traceability during audits and product recalls.
What Makes QT9’s Integrated Platform Stand Out?
QT9 Software provides everything you need to streamline operations, enforce compliance and scale efficiently with a single connected system.
Centralize Documents
Access documents in one place for better document management.
Approve CAPAs
Automate CAPA processes and track corrective actions in real time.
Streamline Audits
Track and manage the scheduling, details and the results of your audits.
Monitor Deviations
Easily track temporary deviations with email alerts and to-do lists.
Minimize Risk
See your risk analysis by assigning risk scores, tasks, priorities, approvals, etc.
Reduce Complaints
Track customer feedback and alert responsible parties with workflows.
Modernize Inspections
Capture inspection details online and link related documents for reference.
Train Employees
Manage employee training on the web with tailored tests.
EBR & DHR
Automate Electronic Batch Records and Device History Records.
QT9 Solutions are Built for Any Industry. Increase your Productivity.
Medical Devices Pharmaceuticals Aerospace Automotive Cannabis Chemicals Cosmetics Electronics Food & Beverages Manufacturing Metals & Mining Plastics
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QT9 is Available in the Cloud or On-Premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work Smarter with Intelligent Automation in Quality and Compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up Implementation with Pre-Validated Software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure Audit-Ready Traceability Across All Processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower Teams With Secure, Self-Service Portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and Resolve Issues Instantly with Real-Time Monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard Faster with an Intuitive, User-Friendly Platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
Boost Productivity with Smart Automation
- Minimize Errors
- Reduce Costs
- Data-Driven Decisions
- Centralize Information
- Streamline & Scale
Minimize Errors
Improve accuracy and minimize human errors
QT9 Software’s automated workflows ensure consistency and accuracy across your quality and compliance processes, reducing risks from manual data entry, missed steps and inconsistent execution. Minimize costly mistakes and support stronger compliance outcomes with automation you can trust.
Reduce Costs
Prevent Costly Mistakes with Integrated Automation
Manufacturing errors lead to expensive rework, missed compliance deadlines result in fines, and delays hurt customer satisfaction. QT9 Software’s integrated automation helps prevent these issues by improving accuracy, streamlining tasks and reducing reliance on disconnected systems—saving you time, money and frustration.
Data-Driven Decisions
Collect Real-Time, Actionable Data to Drive Smarter Decisions
QT9 Software captures and shares accurate, real-time data across your organization, enabling your team to respond quickly to changes and opportunities from any location. Automated workflows and seamless data integration ensure that key metrics flow consistently between modules—such as nonconformance reports, inspections, corrective actions and supplier evaluations—so your teams always work from a single, reliable source of truth.
Centralize Information
Improve Team Communication and Visibility Across Your Organization
QT9 Software’s integrated platform enables real-time collaboration across departments and locations by centralizing data in a single, accessible system. Teams can access up-to-date information to improve transparency and accountability, while automated reminders and notifications keep everyone aligned on report updates, document changes, and approval deadlines—reducing delays and accelerating issue resolution.
Streamline & Scale
Future-Proof Your Quality and Operations with Scalable Automation
As your business grows, managing quality and compliance becomes more complex. QT9 Software’s scalable, integrated automation tools help you handle increasing volumes of data and workflows without adding additional staff or disconnected systems. Automation makes it easier to adapt to changing regulations, customer demands, and internal process updates. With QT9, you can reconfigure workflows quickly, stay agile and confidently scale in a fast-changing market.
Pre-Validated Software Solutions
QT9 solutions are pre-validated for faster compliance.
Why choose a pre-validated solution?
In FY 2023, inspectors issued 483s in ~80% of inspected clinical investigator firms (425 of 693 inspections)
- FDA and ISO compliance out-of-the-box: Achieve regulatory readiness without lengthy manual validation processes.
- Rapid cloud deployment for faster implementation: Go live faster with a pre-validated environment ready for immediate use” emphasizes speed to implementation.
- Audit-ready with timeline traceability: Maintain detailed, time-stamped records to support inspections and audits
- Electronic signature approvals and secure access controls: Enforce compliance while protecting sensitive data
- Continuous validation and updates: Stay compliant as regulations and processes evolve without additional system downtime
What compliance standards need validation?
| • ISO 13485 • ISO 9001 • ISO 14001 • ISO 17025 • AS9100 • MoCRA |
• FDA 21 CFR Part 11 • FDA 21 CFR Part 210/211 • FDA 21 CFR Part 820 & QMSR • EU cGMP • EU MDR • GxP Compliance |
Is IQ, OQ, PQ part of validation?
Yes. QT9 Software includes complete execution of all validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring your systems meet regulatory compliance requirements with confidence.
How does pre-validated software save money?
- Eliminates Internal Validation Costs: Avoid lengthy, expensive internal validation processes.
- Reduces Downtime: Get your software up and running immediately.
- Minimizes Audit Risk: Reduce the chance of failed audits and costly remediation.