The thesis deals with the assurance of regulatory compliance and validation of computer supported laboratory systems in the pharmaceutical industry. It describes the functioning and importance of regulatory authorities and explains the standards and good practice examples to be observed in the validation process. By actively introducing the act on electronic records and signatures, food and drug agencies have succeeded in setting up clear requirements and guidelines in the pharmaceutical industry and thus in gaining their legal validity. Consequently, the information and computer technology are becoming increasingly important in manufacturing pharmaceutical drugs.
The described example of the validation documentation development presents the validation process of a computer-supported laboratory system from the beginning to the end, when such a system becomes usable in the regulated environment and it can be released as such in the manufacturing environment. The computer system validation process is strongly connected with the conception of "data integrity" and is of key importance for the existence of a pharmaceutical company from the viewpoint of regulatory requirements. The last part of the thesis focuses on the meaning of "data integrity" from the viewpoint of regulatory authorities and on some methods of how it can be assured.
Due to the complexity of such systems, compliance assurance costs, and increasingly severe inspections, the computer system validation in the pharmaceutical industry is one of the key elements within the life cycle of pharmaceutical drug manufacturing. The validation process helps to prevent deviations from regulatory requirements and thus enables the pharmaceutical company to focus more intensively on the development and manufacturing of high quality drugs.
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