Implementation of validation activities by management of quality tools for digitalization

Economy and management of the enterprise

The relevance of this study is due to the changing requirements of regulatory documents to the activities of industrial enterprises, especially in the field of production of medicines in modern economic conditions. Currently, the processes of validation of industrial enterprises are regulated by a fairly wide range of legislative, regulatory documents, as well as documentation developed by the enterprises themselves. The difficulty in managing such documented information lies in the fact that a thorough analysis of the diverse and often conflicting requirements is necessary to ensure, on the one hand, the appropriate quality of drug production and, on the other, compliance with the relevant requirements, while ensuring their traceability and feasibility. The existing problems in the field of high-tech production of pharmaceutical enterprises, including to ensure the quality of production of medicines. The analysis of legislation, regulatory documents in terms of requirements for the implementation of validation processes necessary to ensure the effective operation of the pharmaceutical company in the field of quality management. The concept of management of the system of validation measures of high-tech industrial production of the pharmaceutical industry based on the use of software in the field of project management. The article is devoted to the choice of the optimal approach for the implementation of validation measures carried out at pharmaceutical enterprises in order to ensure compliance with the requirements of regulatory documents and quality management of production of medicines. The directions of further research the authors see in the development of a system of validation measures based on software and research on their basis. The approach under consideration includes determining the list of required validation measures of an industrial pharmaceutical enterprise, preparing an information base for the use of software, dividing the project into phases and using the MS Project program. This software allows you to carry out the necessary level of planning of the workflow, the effective allocation of resources in relation to the tasks and goals. The proposed management system is designed to ensure transparency of management decisions and ensure the success of the project within the framework of the formation and implementation of the system of validation measures of the industrial pharmaceutical enterprise of the national economy.