Quality Assurance

The article examines pharmacovigilance and quality management processes under conditions of scaling up the production of biotechnological veterinary medicinal products. The necessity of overcoming the fragmentation of management systems and eliminating information gaps between production units and pharmacovigilance services is substantiated, which is a critical factor in the context of the digital transformation of the industry.

The next industrial revolution commonly known as Industry 4.0 represents the idea of interconnected manufacturing, where intelligent devices, systems and processes exchange information, resources and artifacts to optimize the complete value-added chain and to reduce costs and time-to- market. Industrial software ecosystems are a good example how the latest digitalization trends are applied in the industry domain and how with the help of industrial IoT applications the production process can be optimized.

Article deals with topical issues of quality management of medical services and their implementation in practical activity. For quality of research results, serious problems are created by a lot of objective and subjective factors. To eliminate the problem factors, the course was aimed at developing national standards in the field of laboratory medicine, using international experience that regulate the requirements for the organization of clinical diagnostic laboratories and laboratory analysis facilities. The acute problem of laboratory research is to ensure the accuracy of the results.