Informational model of the system of integral quality management for pharmaceutical companies.

V. A. Zhuk, Yu. M Penkin

ABSTRACT

         Modernization of pharmaceutical industry which will comply to the requirements of GMP-standards requires much input. The selection of informational model of the enterprise of new generation will make it possible to transform the existing concept of large or medium pharmaceutical manufacturers. In compliance with the requirements of ISO and GMP standards, the concept of the system of integral quality management (IMQ) will provide the foundation for the pharmaceutical enterprise functioning. An adequate informational model of the enterprise IMQ system represents a corporative information system of the module type, which functions together with the enterprise personnel on the logic-programme principles of intellectual expert medium with the aim of optimization of functioning of all levels of the enterprise, as well as the realization of all management functions, on the selected quality factors. In order to minimize costs and time for creation and implementation of the ИМК information systems at all medium and large pharmaceutical enterprises, uniform standards of functioning of such information systems, which will include the uniform requirements to the software, should be developed.

Keywords: quality control system, information model.