ICH Q10 Compliance Made Simple
Implement a robust, lifecycle-driven pharmaceutical quality system with QT9 QMS, supported by QT9 ERP for connected manufacturing and operational data. Together, they help organizations meet ICH Q10 expectations for risk-based control, continuous improvement, and global regulatory compliance.
Centralized Data
QT9 QMS centralizes quality documentation, with QT9 ERP supporting access to current operational data.
Continuous Improvement
QT9 QMS drives continual improvement, supported by QT9 ERP data to improve efficiency across operations.
Change Management
QT9 QMS standardizes and controls changes, while QT9 ERP reflects approved changes across operational processes.
ICH Q10 Alignment
QT9 QMS supports ICH Q10 requirements, with QT9 ERP providing operational visibility to improve productivity and consistency.
ICH Q10 Pharmaceutical Quality Framework
QT9 QMS aligns with the four core elements of ICH Q10: Process Performance and Product Quality Monitoring, CAPA, Change Management, and Management Review. Supported by QT9 ERP for connected operational data, QT9 helps coordinate operations, reduce compliance risk, and improve product quality through built-in automation and end-to-end traceability.
Risk-based CAPA management
Initiate CAPAs from deviations, complaints or audits. Assign root cause investigations, corrective actions and effectiveness checks with traceable workflows.
Process performance monitoring tools
Use QT9’s real-time dashboards and reports to monitor quality KPIs and process trends, in line with ICH Q10 expectations for proactive quality oversight.
Automated change control
Track and approve changes across documents, products, equipment or processes. Link changes to risk assessments, training and impacted departments.
Integrated management review
Schedule, conduct and document management reviews with live metrics and system-wide performance data, all centralized in one platform.
End-to-end Electronic Batch Records
Capture batch production data digitally and tie it to QMS events such as deviations, changes and CAPAs for full traceability.
Supplier and material quality oversight
Qualify vendors, track supplier performance and link quality issues directly to supplier records to maintain consistent product quality.
Training linked to SOP and change events
Automatically assign and track role-based training related to new or revised procedures, products, or processes.
See how QT9 QMS and QT9 ERP stack up against ICH Q10
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.
Pre-validated QMS & ERP software
QT9 platforms are pre-validated for accelerated compliance.
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FDA and ISO compliance out-of-the-box
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Rapid cloud deployment for faster implementation
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Audit-ready with timeline traceability
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Electronic signature approvals and secure access controls
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Continuous validation and updates
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• ISO 13485 |
• FDA 21 CFR Part 11 |
QT9 includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your software to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
FAQ: ICH Q10
ICH Q10 is a model for an effective pharmaceutical quality system (PQS). Its guidelines were developed by the International Council for Harmonization (ICH), which was established in 1990 by regulatory and industry bodies from across the globe, including Europe, the United States and Japan, in an effort to streamline pharmaceutical regulations in an increasingly global market.
Q10 is one section of a three-part model that includes ICH Q8 and ICH Q9, each covering different aspects of pharmaceutical product development and manufacturing. Q8 focuses on development phases, Q9 on risk management and Q10 on quality management systems. The model is based on traditional Good Manufacturing Practice (GMP), but seeks to modernize it with a more holistic view of quality that emphasizes continuous improvement.
ISO 9001 and cGMP act as the foundation for a PQS as outlined in the Q10 guidelines. ICH Q10 takes those guidelines a step further, seeking to tailor the general nature of current quality guidelines to meet the unique needs of the pharma industry, with the goal of a stronger, more efficient and more effective industry.
Q10 offers a framework for a PQS that applies to all phases of pharmaceutical development, manufacture, maintenance and discontinuation.
The PQS focuses on four key elements:
- Process performance and product quality monitoring
- Corrective and preventive actions (CAPAs)
- Management review of process performance and product quality
- Change management
ICH Q10 emphasizes management responsibility and commitment to quality, especially in the allocation of resources, oversight of the PQS, and continuous improvement of process performance, product quality and the PQS itself.
QT9 QMS software helps pharmaceutical companies streamline and centralize compliance with ICH Q10. QT9 QMS is an end-to-end solution with more than 25 modules that come standard, including Risk Management, Document Control, Management Review, Change Management and CAPA Management.
Our cost-effective, highly rated QMS is backed by an intuitive user interface, free software updates, full customer support, an available ERP integration and Business Intelligence tool. Call today to schedule a demo or sign up for a free trial.
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