ICH Q10 Pharmaceutical Quality System, Made Simple
Implement a robust, lifecycle-driven pharmaceutical quality system with QT9 QMS. Meet ICH Q10 expectations for risk-based control, continuous improvement and global compliance.
Centralize Data
Centrally manage documentation and ensure access to the most current information.
Drive continuous improvement
Consistently improve quality through more efficient operations.
Manage Change
Standardize and integrate processes to minimize errors.
Meet ICH Q10 standards
Improve productivity and profitability with a QMS geared to industry best practices.
ICH Q10 pharmaceutical quality management system
QT9 QMS aligns with the four core elements of ICH Q10: Process Performance and Product Quality Monitoring, CAPA, Change Management, and Management Review. With built-in automation and traceability, QT9 QMS helps you harmonize operations, reduce compliance risk and improve product quality.
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.
Advanced ICH Q10 pharmaceutical quality management
QT9 QMS provides an easy-to-use framework for meeting ICH mandates spanning the product lifecycle.
Change Management
Document Control, Change Control modules
Continual Improvement
Quality Events, Management Review modules
Lifecycle Goals-Development
Product Design Controls, ECR/ECN modules
Outsourced Activities & Materials
Supplier Evaluation, Surveys and Corrective Actions modules
Control of Production & Service Provision
Inspections module
Control of Monitoring & Measuring
Calibrations module
Process Performance & Product Quality
Quality Events, Audit Management modules
Control of Nonconforming Products
Nonconforming Products, Corrective Actions modules
Corrective and Preventive Actions (CAPA)
CAPA Management module
Pre-validated QMS software
QT9 QMS is 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 13585 |
• FDA 21 CFR Part 11 |
QT9 QMS 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 QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your QMS 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.
Unlimited support included
Have a question? QT9 support is here to help for all QT9 QMS users.
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