Abstract

The article summarises the main results of a study investigating integrated development and implementation of an information analytical database of reference standards in the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of Russia (FSBI «SCEEMP»). The subject of the research is an information analytical database of reference standards designed to assess the quality, efficacy and safety of medicines. The aim of the study was to create the concept of an information analytical database of reference standards based on object-oriented approaches. The database was created in response to the need for improving the efficiency of certain types of activities of the FSBI «SCEEMP» which has already automated some of its processes. The paper discusses the key prerequisites for the creation of an integrated specialised information technology product as a way to improve overall performance. A general procedure for the development of an information and analytical database is presented, taking into account the tasks set and the established requirements for the functionality of the information and analytical system. The paper describes the implemented solutions, as well as strategies for their improvement. The operation algorithms of the information-analytical database of reference materials allow for its further modernisation, as well as greater automation of actions with documents and data, incorporation of new standardised reference books, ready-made templates, as well as modification in case any changes are made to business processes, legislation or technical and technological aspects of using reference standards.

Highlights

  • The article summarises the main results of a study investigating integrated development and implementation of an information analytical database of reference standards in the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of Russia (FSBI «SCEEMP»)

  • Объект «Испытания стандартного образца в рамках проводимой аттестации» может содержать до 16 характеризующих его атрибутов

  • Запись о стандартных образцов (СО) — основообразующий объект, от него проводится последовательная цепочка связей к пакетам документов и набору данных, полученных в результате аттестации СО экспертами

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Summary

Introduction

The article summarises the main results of a study investigating integrated development and implementation of an information analytical database of reference standards in the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of Russia (FSBI «SCEEMP»). Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Ведомости Научного центра экспертизы средств медицинского применения 2019. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2019.

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