Streamline Quality and Compliance with QT9 QMS Software

QT9 QMS is an all-in-one, pre-validated electronic quality management system that enables regulated organizations to automate compliance efforts, centralize quality processes and maintain audit readiness. Available in the cloud or on-premise, it’s 25+ modules offer end-to-end quality management across the product lifecycle.

QT9 QMS is built for regulated manufacturing environments and offers native integration with QT9 ERP, enabling seamless data flow between quality and operations.

QT9 QMS comes pre-validated for easy compliance with standards like FDA 21 CFR Part 11, ISO 9001 and AS9100. It includes IQ, OQ and PQ validation protocols, enabling faster implementation and reduced validation effort.

QT9 QMS provides all 25+ integrated modules out-of-the box, including document control, CAPA, audit management, employee training and risk management. Available in cloud-based or on-premise delivery, QT9 QMS offers flexible deployment, integrated customer, supplier and employee web portals, plus real-time data to enhance business decisions.

Users can automate device history records (DHR/MDR/MDF) and batch records (MBR/EBR) in one secure solution. 

QT9 QMS is designed for industries that must meet strict regulatory and quality requirements, such as:

• Medical devices
• Pharmaceuticals and life sciences
• Aerospace and automotive
• General manufacturing
• Food and beverage processing

QT9 QMS provides a full suite of more than 25 integrated quality management applications and features, including:

• Centralized document control with revision tracking
• CAPA and non-conformance management
• Audit management and scheduling
• Training and certification tracking
• Risk management and change control
• Supplier quality management
• Product design and engineering change controls
• Dynamic reporting for full traceability and visibility
• Electronic signature approvals

IQ/OQ/PQ validation 

QT9 QMS simplifies compliance by offering:

• Audit management module for continuous audit readiness
• Electronic signatures and built-in audit trails
• Automated workflows and approvals
• Built-in validation protocols (IQ, OQ, PQ)
• Real-time traceability across quality processes

This ensures organizations stay continuously audit-ready and aligned with global regulations.

QT9 QMS supports major global quality regulations and standards, including:

• FDA 21 CFR parts 11, 210, 211 and 820
• ISO 9001 and ISO 13485
• AS9100 and IATF 16949
• EU MDR and GMP frameworks

QT9 QMS can be implemented in as little as 30 days due to its pre-validated environment and ready-to-use modules, significantly reducing deployment time compared to traditional QMS systems. Implementation time varies, however, depending on several factors, including company size and complexity, current processes and procedures, and the number of internal resources dedicated to implementation.

QT9 QMS comes pre-validated with Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols already completed, reducing internal validation effort and accelerating go-live.

Both. QT9 QMS offers flexible deployment options, including both cloud-based and on-premise environments, allowing organizations to align with their IT, security and compliance requirements.

QT9 QMS improves performance by:

• Automating quality workflows and reducing manual work
• Providing real-time visibility into quality data
• Identifying issues early and triggering corrective actions
• Minimizing errors, defects and compliance risks

This leads to faster decision-making, improved product quality and reduced operational disruption.

Yes. QT9 QMS integrates with ERP systems—but more importantly, it offers a native, built-in integration with QT9 ERP, creating a single, unified platform for quality, manufacturing and business operations.

Unlike typical QMS tools that rely on APIs or middleware, QT9 QMS and QT9 ERP were developed together on a shared architecture. This allows data to flow seamlessly between systems in real time, without synchronization delays, integration failures or duplicate data entry.

Absolutely. QT9 QMS is designed to scale from small teams to global enterprises, supporting multi-site operations, increasing data volumes and expanding compliance requirements without added complexity.

Yes, QT9 QMS has won awards for being user friendly! Its user-friendly interface makes it easy for teams to adapt quickly. Licensing also includes training resources and support to ensure successful onboarding and long-term use.