The authors consider the application of the system approach for building the information space for
the life cycle of the production of medicines. Visualization is provided by models in the IDEF0 notation.
This approach was designed to increase visibility and simplify the perception of complex technological
processes.
The QbD principle is based on the construction of the information shell, which is well-proven and
will be understood by a wide range of readers. To implement it on the basis of a system approach, the
Shuhart-Deming cycle is used, which allows obtaining all the necessary information about the general
concept of the technological processes being built.
The combination of the PDCA cycle and the system approach is given. The system approach opens
the possibility of designing and building a single information space, which is a necessity. The criterial
approach is analyzed and system management models are constructed in Melentiev’s notation.
The article provides reference materials in the form of tables and diagrams that are required to accompany
and explain the process of building individual units and subsystems of the unified information
space being developed.
Developed control systems are based on the initial training and further use of artificial intelligence
subsystems, which is necessary to significantly reduce the number of errors in calculations at all stages
of the formation and application of projected systems. Technologies, which in the modern world are
called artificial intelligence, have long and successfully been used in various fields of life of modern
society. Their implementation should be carried out strictly in stages with strict control. General provisions
and features of control subsystems are also specified in this article.
Key words
life cycle of medicines, preclinical researches, clinical researches, functional diagram, IDEF0 notation, SAP ERP systems, databases, Sheukhart-Deming’s cycle, V. A. Melentiev’s notation, objective functions, criteria for evaluating technological operations, development prospects.
