Automate ICH Q10 pharmaceutical quality management
Centralize and integrate your quality processes in one platform for easier insight and collaboration.
Meet and maintain ICH Q10 quality system standards
- Risk Management
- Change Management
- Management Responsibility
- Continual Improvement
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Risk Management
QT9 QMS helps to systematically identify, assess and mitigate potential risks throughout the pharmaceutical product lifecycle. Our Risk Management module provides a built-in risk assessment tool that integrates with other applications, such as corrective actions and engineering change requests, streamlining and simplifying your risk management activities. Risk assessment statuses can be quickly viewed from your dashboard, with real-time information accessible anytime from anywhere.
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Change Management
QT9 QMS’s Change Control module seamlessly links your change management key activities, including document control, deviations and corrective actions. Automated change control processes let you link change control records to processes and departments, manage approvals and give you real-time insight into the status of change control tasks.
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Management Responsibility
Demonstrate commitment to quality with automated document approval and management available in QT9 QMS Document Control module, with automated routing, reminders and electronic signature capabilities. Quality system policies and procedures are available in a centralized location, accessible anytime, from anywhere, with version control and traceability built in. Control supplier and customer interactions easily through our Supplier Portal and Customer Portal, keeping the lines of communication open and relevant data available for ultimate interaction and assessment. Our Management Review module melds quality system stats together, giving you a centralized location to monitor and report on the status of your company’s PQS.
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Continual Improvement
Almost all of our QMS modules support continuous improvement of our customers’ products and processes, including:
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CAPA Management
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Quality Events
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Customer Feedback
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Deviation Management
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Supplier Evaluations
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FMEA
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Inspections
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Employee Training
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Advanced ICH Q10 pharmaceutical quality management
QT9 QMS helps you meet ICH Q10 standards.
Frequently Asked Questions: ICH Q10
What is 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.
How is ICH Q10 different from other quality management requirements?
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.
What are the main components of ICH Q10 guidelines?
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.
Do I need to be compliant with ICH Q10?
Even though ICH Q10 is a voluntary compliance framework, more and more pharma and biotech companies are using it. Pharmaceutical companies who choose to implement the Q10 compliance model demonstrate greater assurance of and commitment to quality. For pharmaceutical companies marketing products globally, the ability to demonstrate ICH Q10 compliance facilitates more efficient approval of their drug in more markets.
How can QT9 QMS help reach and maintain ICH Q10 compliance?
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.
Track all your ICH Q10 compliance records in one place.
QT9's easy-to-use ICH Q10 quality management system makes traceability and transparency simple for any life science company.
Built-In Dashboard
Quickly view ICH Q10 records from the QT9 dashboard, and easily personalize the view.
Traceability & Transparency
QT9 QMS includes web portals for customers, suppliers and employee training.
Mobile-Friendly
Manage ICH Q10 records from your desktop, tablet or mobile device from anywhere you have internet.
QT9™ QMS is your flexible ICH Q10 Quality Management System
QT9 lets you implement modules based on what's best for your organization.
Modules for any business size
With multiple modules to choose from, there's a solution for nearly anyone.
A system that scales with you
Whether you are a large corporation or a small start-up you can use as many modules as you want.
Cross-Platform Support
Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.
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