Validation

-Software Validation: The subject of software validation has been an essential requirement of quality management by updating the ISO 13485 Medical Devices Quality Management System. It is determined according to the usage area and competence of the product that it is part of the standard software that should be applied. In some applications, the software is a stand-alone product, in some cases it may be a direct part of the medical device, and in other cases, a part of the equipment that contributes to the production line of products serving in the medical field. Evaluating and examining the scope of the software used in the field of health services is a laborious process since it requires experience. In the light of the information we receive from you, the validation report that we have prepared, examines and plans the studies from the feasibility studies to the retirement of the software at the beginning of the software life cycle, by determining risk control methods based on the risk analysis. With this report, the continuity, improvement, traceability and archiving of the software are controlled by creating quality documents.

- Usability Validation: One of the risks in a software that is desired to be validated by software validation is the usability risk. If the software itself is a product or if the software is a direct part of the medical device, software validation alone is not sufficient to validate the software. A software that produces quality results may not always be a product that can be used comfortably and effectively by the user base. Usability is the examination of the software interaction with the human factor, which is one of the environmental factors derived from the software, from a positive quality perspective. The quality management system for medical devices evaluates the problems arising from the use as a risk, and we report that these risks can be controlled with usability validation. With this report, manufacturers have the opportunity to demonstrate the superiority of their products, ease of use always ensures being a preferred product and gives confidence.

-Machine Software Validation: Manufacturers producing within the scope of health services can use one or hundreds of electronic and mechanical equipment. Today's machines work like a small production block, which promises product quality, which can do a few jobs together that has already left behind working with full arm power. This capability is provided to the devices with electronic cards. They are managed from the buttons or touch screen with the sections we call the user interface. According to the quality management system for medical devices, software validation is required when checking the reliability of these machines. Health services machine software risk analysis, validation and re-validation, maintenance repair, archiving, updating, retirement and destruction are examined.

-Process Validation: It is a requirement of the quality system in pharmaceutical production. A good process validation, well-defined criteria specially prepared for the manufacturer, provides evidence for the sanctions and solutions in the R&D and production line, ensuring uniformity, reproducibility, quality, and control the manufacturer's weakness cost.

-Gamma Validation: One of the sterilization methods, Gamma is the process of validation of manufacturers that produce end products that need to be sterilized by applying ISO 11737-1 standard in accordance with the quality management system.

-Sterilization Validation: It is the process of validating the process by applying the ISO 11737-2 standard in accordance with the quality management system of the manufacturers that produce the final product that should be sterile. The reports we have prepared for you are important in terms of being a process that is customized according to the product and its critical points are well studied and constantly improved.

-Transport Validation: According to the quality management system, it is not sufficient for the final product to be produced and completed in quality competence. Because products should be delivered under the appropriate conditions according to their characteristics, while maintaining their properties. Many products are only possible in this process by proving their validity and continuity. Our reports concern storage officers, those working in the transport and distribution unit, those dealing with active substance logistics, and the management units of manufacturers. Provides information about the subject.

-Filling validation: A verification and validation report is prepared by examining the requirements of the appropriate standards. The rigor of the process affects the final product quality, and its applicability and efficiency relieve the burden of the manufacturer.

-Injection Validation The repeatability of the main and critical elements of the injection process, pressure, temperature, flow rate and cooling rate parameters are examined in terms of quality and validated with the report prepared. The rigor of the process affects the final product quality, and its applicability and efficiency relieve the burden of the manufacturer.

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