AUTOMATED INFORMATION SYSTEMS AS ELEMENTS OF THE PHARMACEUTICAL ENTERPRISE QUALITY MANAGEMENT SYSTEM

Abstract

Urgency of the research. With the development of information technology and new management practices, there has been a convergence and often a merger of quality management and information technology practices. At present, concepts based on the integration of quality management systems and automated information systems are becoming increasingly important.Actual scientific researches and issues analysis.In the process of researching specialized scientific and technical litera-ture, modern trends and problems of introduction of information technologies in the quality management system were analyzed.Uninvestigated parts of general matters defining. An unsolved problem is to ensure the quality of use of automated infor-mation systems at a pharmaceutical enterprise integrated into an enterprise quality management system based on the requirements of the international GMP standard and the Guidelines ST-N MOH 42-4.0: 2016 “Medicines. Good manufacturing practice".The research objective. The purpose is to systematically analyze the methodological foundations of quality assurance, through the introduction and use of AIS, aimed at creating favorable conditions for improving the efficiency of the quality management system in the pharmaceutical industry.The statement of basic materials. The issues of construction and improvement of quality management system based on existing technologies for automated production are considered. The structure of the computer quality management system and the mechanisms of its information support are determined. The methods of integration of specialized software systems are alsoanalyzed and the concept of integration of them into the quality management system is proposed.Conclusions.Based on the critical analysis, a number of unresolved problems related to the development, implementation and use of automated information systems based on international standards were separated, as well as the scientific hypothesis of the effective implementation and use of automated information systems integrated into the quality management system of the pharmaceutical enterprise was put forward.