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kjc 7/24/2012 4:35:18 AM If you are a resident of the EEA, you might have noticed that we are unable to remove your PII data. If you would like to have your data deleted, please follow the instructions on the EU PII Data Confidentiality Page. Thank you for your patience and understanding. -- Our Privacy Policy can be read here. IMPORTANT NOTICE: The website is not affiliated with the European Union or any other public or private sector organisation. The EU GDPR provides that you have the right to be informed about how your personal data is processed, and have the right to access the data that is being processed about you, correct it if you think it is wrong, or object to it if you think it is illegal. More information can be found at the European Union website, By Design-based Systems To enhance the risk-assessment process, primarily by improving the quality of the risks, is known as Quality by Design (QbD). It is the quality that is part of the design and process of a product. This design and process is controlled by the Quality Management System (QMS). How to qualify a QMS? An AQL (acceptable quality level) based quality management system includes the design and process, and consists of 1. Quality Target, 2. Quality Management Processes, 3. Quality Control Processes, 4. Quality Assurance (QA) Processes, and 5. Quality documentation. In the evaluation of the quality management system, the following points have to be evaluated and verified: 1. Is the system integrated? 2. Are the processes validated? 3. Is the quality documentation available? 4. Does the QMS fulfill the requirements of the relevant provisions? 5. Do the quality requirements of the projects and standards materialize? These verification and qualification results guarantee the compliance of the QMS with the relevant provisions and standards. How can QMS be integrated? Integration of the Quality Management System (QMS) into the production process is a prerequisite for the efficient and successful execution




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