Validation of pharmaceutical information systems: databases and laboratory information management systems
The article describes the basic principles of validation of the databases and laboratory information management systems used by pharmaceutical organizations. The principles are arranged on the basis of international OMCL network requirements and ISO standards. The article presents the general approa...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
NEICON ISP LLC
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/48 |
| _version_ | 1797199092220166144 |
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| author | K. A. Koshechkin E. V. Gladkaya Ya. Yu. Kondratieva |
| author_facet | K. A. Koshechkin E. V. Gladkaya Ya. Yu. Kondratieva |
| author_sort | K. A. Koshechkin |
| collection | DOAJ |
| description | The article describes the basic principles of validation of the databases and laboratory information management systems used by pharmaceutical organizations. The principles are arranged on the basis of international OMCL network requirements and ISO standards. The article presents the general approaches to validation of these types of information systems and evaluation of soft- and hardware choices, and the requirements to the procedure of installation and the settings of those. It contains the requirements to test data sets and general methodology for conducting the validation tests. Additionally, it covers the possibility to validate not only new software, but also the software currently in use. |
| first_indexed | 2024-03-07T19:18:33Z |
| format | Article |
| id | doaj.art-e6a9239aed2b48f99804636b2da18d94 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:10:15Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-e6a9239aed2b48f99804636b2da18d942024-04-21T11:46:32ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0103232746Validation of pharmaceutical information systems: databases and laboratory information management systemsK. A. Koshechkin0E. V. Gladkaya1Ya. Yu. Kondratieva2Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThe article describes the basic principles of validation of the databases and laboratory information management systems used by pharmaceutical organizations. The principles are arranged on the basis of international OMCL network requirements and ISO standards. The article presents the general approaches to validation of these types of information systems and evaluation of soft- and hardware choices, and the requirements to the procedure of installation and the settings of those. It contains the requirements to test data sets and general methodology for conducting the validation tests. Additionally, it covers the possibility to validate not only new software, but also the software currently in use.https://www.vedomostincesmp.ru/jour/article/view/48валидацияинформационные системыинформатизация здравоохраненияавтоматизированные информационные системывычислительные информационные системыперсональный компьютерvalidationinformation systemscomputerization of healthcareautomated information systemscomputable information systemspersonal computer |
| spellingShingle | K. A. Koshechkin E. V. Gladkaya Ya. Yu. Kondratieva Validation of pharmaceutical information systems: databases and laboratory information management systems Ведомости Научного центра экспертизы средств медицинского применения валидация информационные системы информатизация здравоохранения автоматизированные информационные системы вычислительные информационные системы персональный компьютер validation information systems computerization of healthcare automated information systems computable information systems personal computer |
| title | Validation of pharmaceutical information systems: databases and laboratory information management systems |
| title_full | Validation of pharmaceutical information systems: databases and laboratory information management systems |
| title_fullStr | Validation of pharmaceutical information systems: databases and laboratory information management systems |
| title_full_unstemmed | Validation of pharmaceutical information systems: databases and laboratory information management systems |
| title_short | Validation of pharmaceutical information systems: databases and laboratory information management systems |
| title_sort | validation of pharmaceutical information systems databases and laboratory information management systems |
| topic | валидация информационные системы информатизация здравоохранения автоматизированные информационные системы вычислительные информационные системы персональный компьютер validation information systems computerization of healthcare automated information systems computable information systems personal computer |
| url | https://www.vedomostincesmp.ru/jour/article/view/48 |
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