QT9 Software

QT9 Software is an integrated quality and operations software provider serving regulated manufacturing industries worldwide. The company offers a unified suite of solutions — QT9 QMS, QT9 ERP, and QT9 MRP — designed to simplify compliance, reduce manual work, and drive operational excellence. With over 1,200 customers and recognition on G2 for ease of use, customer support, and rapid ROI, QT9 is a trusted partner for organizations in life sciences, medical devices, pharmaceuticals, aerospace, automotive, chemicals, cosmetics, electronics, food and beverage, metals and mining, and plastics manufacturing.

Founded by Brant Engelhart, who designed the first version of the platform himself, QT9 has grown over two decades into a company of more than 60 team members serving thousands of global users. QT9's mission is to empower organizations in regulated industries with innovative, out-of-the-box solutions that simplify compliance and drive operational excellence — delivered with integrity, care, and a relentless focus on customer success. The platform is available as both a cloud-based and on-premise deployment, offering flexibility to match any IT strategy without compromising security or speed.

QT9 QMS — Quality Management System

• Document Management: Centralise all documents in one place for streamlined access and version control.
• CAPA Management: Automate corrective and preventive action processes and track corrective actions in real time.
• Audit Management: Track and manage the scheduling, details, and results of internal and external audits.
• Deviation Tracking: Monitor temporary deviations with automated email alerts and to-do lists.
• Risk Management: Assign risk scores, tasks, priorities, and approvals to support comprehensive risk analysis.
• Complaint Management: Track customer feedback and alert responsible parties through automated workflows.
• Inspection Management: Capture inspection details online and link related documents for reference.
• Employee Training: Manage and deliver employee training on the web with tailored tests and tracking.
• Calibration Scheduling: Define calibration intervals per equipment to maintain instrument compliance.

Platform Capabilities

• Streamlined Automation: Built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors and accelerating decision-making.
• Pre-Validated Software: Every module and feature is tested and documented for compliance, enabling faster go-live and eliminating costly internal validation processes — particularly valuable for life sciences companies.
• End-to-End Traceability: Timeline-based traceability tracks every action, change, and event in real time, supporting inspections, audits, and product recalls with complete visibility into process and product history.
• Role-Based Access Portals: Dedicated web portals for employees, suppliers, and customers enable secure self-service access to documentation and data, streamlining cross-organizational collaboration.
• Real-Time Visibility: Live dashboards and automated alerts enable proactive responses to nonconformances, minimize downtime, and improve compliance outcomes.
• User-Friendly Design: An intuitive interface minimizes the learning curve for startups and enterprises alike, empowering users to work confidently and remain audit-ready from day one.

Life Sciences and Regulated Industry Features

• Pre-validated platform to support faster time to market for life sciences companies.
• Automated Device History Record (DHR) management for medical device manufacturers.
• Streamlined Electronic Batch Record (EBR) capabilities for pharmaceutical operations.
• Support for GDPR and EU MDR compliance requirements.
• Traceability architecture designed to meet the demands of FDA-regulated and ISO-certified environments.

Product Suite

• QT9 QMS: All-in-one electronic Quality Management System for compliance automation and quality operations.
• QT9 ERP: Enterprise Resource Planning software designed for regulated and manufacturing businesses.
• QT9 MRP: Material Requirements Planning software to streamline production and inventory operations.

Customer Success and Support

• Unlimited training resources available to all customers.
• Unlimited support with dedicated support teams providing immediate assistance.
• Annual software upgrades driven by end-user feedback, regulatory standard changes, and competitive enhancements.
• A customer-driven innovation model focused on refining and streamlining systems in close collaboration with users.
• Case studies and a resource library available to help customers maximize platform value.

QT9 Software's integrated platform is purpose-built to help regulated manufacturers minimize errors, reduce costs, centralize information, and scale operations efficiently — all within a single connected system that supports continuous improvement and enterprise-wide compliance.