Our Quality System
Austrianova is committed to the highest standards of product safety, customer satisfaction, intended performance and regulatory compliance throughout our R&D and GxP manufacturing and services. These fundamental quality standards at Austrianova apply to all employees in every function and operation.
To achieve this level of quality, Austrianova has implemented a comprehensive Quality Management System (QMS).
The policies and principles of the Austrianova QMS are based on GXP principles and are designed to help Austrianova to adopt a systematic approach to quality. Implementation of these procedures ensures that we consistently meet the safety, efficacy and quality requirements expected by international regulatory bodies as well as by our collaborators and customers.
Austrianova is committed to providing quality products through:
- Satisfaction of customers/regulatory agencies
- Building quality, safety and efficacy into the product during development and manufacturing
- Adherence to proven procedures and total commitment to meeting and exceeding customer/regulatory requirements Adherence to proven procedures and total commitment to meeting and exceeding customer/regulatory requirements
- Adherence to proven procedures and total commitment to meeting and exceeding customer/regulatory requirements
- Adequate training of our employees
- Maintaining an organisational structure that fosters continuous improvement
- Integrated risk assessment
- Management involvement and responsibility
GMP Cell Production
Quality Management System
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