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Conceptualisation of an information analytical database of reference standards

https://doi.org/10.30895/1991-2919-2019-9-1-49-53

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.

About the Authors

D. P. Andreev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Head of the Department for Systems Analysis and Information Systems Support of the Information Technology Division 

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



A. V. Kozlovich
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Deputy Head of the Department for Systems Analysis and Information Systems Support of the Information Technology Division 

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



References

1. Volkova RA, Fadeikina OV, Movsesyants AA, Borisevich IV. Experience of L. A. Tarasevich State Institute of Standardisation and Control of Medical Biological Products in the development and certifi cation of reference standards of medicinal immunobiological products. Standartnye obraztsy = Reference Materials. 2011;(4):17–21 (In Russ.)

2. Fadeikina OV, Volkova RA. Elaboration of certifi cation procedures for reference standards of biological drugs. Khimiko-farmatsevticheskiy zhurnal = Pharmaceutical Chemistry Journal. 2017;51(8):716–21 (In Russ.) https://doi.org/10.1007/s11094-017-1680-6

3. Koshechkin KA, Olefir YuV, Merkulov VA. Management of information support of the life cycle of medicines. Conceptual approaches to the use of elements of CALS/PLM technologies for information support of the life cycle of medicines. Moscow: Poligraf-Plus; 2015 (In Russ.)


Review

For citations:


Andreev D.P., Kozlovich A.V. Conceptualisation of an information analytical database of reference standards. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2019;9(1):49-53. (In Russ.) https://doi.org/10.30895/1991-2919-2019-9-1-49-53

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ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)