Implementation of automated information systems into the work of the certification body of the federal state budgetary institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

The article describes the system of electronic document management related to the certification of medicinal immunobiological products (MIBP) in the Scientific Centre for Expert Evaluation of Medicinal Products», as well as historical aspects of its development. It also provides a brief description of CALS - the resources introduced into the expert institution’s activities, which are necessary for maintaining the life cycle of medicinal products. It specifies the main tasks that could be solved with the help of the IS «Document flow related to certification of MIBPs». The article enumerates the main development stages of the information system and its functional capabilities. It contains a review of certain modules of the IS «Document flow related to certification of MIBPs», implemented to meet modern standards of information security. It also summarizes the findings of the development of the IS «Document flow related to certification of MIBPs». The prospects of using the IS «Document flow related to certification of MIBPs» in the expert and scientific activities of the institution are also provided.

информационная система, информационная система «Документооборот сертификации МИБП», автоматизация, документооборот, электронная цифровая подпись, information system, the information system «Document flow related to certification of MIBP», automation, document management, electronic digital signature

1. Federal Law of Russian Federation of 17.09.1998 ¹ 157-FZ «On immunoprophylaxis of infectious diseases».

2. Federal Law of Russian Federation of 27.12.2002¹ 184-FZ «On technical regulation».

3. On the introduction of the system of state registration and certification of medical immunobiological preparations. Resolution of the State Committee on Sanitary and Epidemiology Surveillance of the Russian Federation¹ 5, 03.06.1994 (with the «Regulations on the state registration, certification and state control over the quality of medical immunobiological preparations in the Russian Federation»).

4. Petrosyants VA, Kozlovich AV. The influence of automated laboratory information systems on the changes in operating procedures of an expert institution. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2014; (4): 55–8 (in Russian).

5. Koshechkin KA. Perspectives of using CALS / PLM-technologies in the pharmaceutical industry of the Russian Federation. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2014; (1): 47–50 (in Russian).