Validation of pharmaceutical information systems: general provisions
Nternational practices comprise integrated common approaches to validation of information systems, used in pharmaceutical industry by various organizations and that affect the results of their work. The purpose ofvalidation is to assure that the results, obtained with the help of an information syst...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/28 |
| _version_ | 1826566759912570880 |
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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 | Nternational practices comprise integrated common approaches to validation of information systems, used in pharmaceutical industry by various organizations and that affect the results of their work. The purpose ofvalidation is to assure that the results, obtained with the help of an information system are reliable. Validated system ensures accurate results and reduces the risk of errors. The article describes basic principles of the validation of pharmaceutical information systems. The principles are constituted on the basis of international requirements of OMCL system and international standards of ISO system. The article provides the classification information systems used in pharmaceutical organizations. It also describes basic concepts of validation of information systems, such as version management, validation testing, change management, requirement consideration. Basic requirements for application of risk management system to creation of concept devoted to pharmaceutical information system validation are also provided. |
| first_indexed | 2024-03-07T19:17:57Z |
| format | Article |
| id | doaj.art-4be77973a1de423d9d2ef8e33ed999e5 |
| institution | Directory Open Access Journal |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| last_indexed | 2025-03-14T10:56:46Z |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj.art-4be77973a1de423d9d2ef8e33ed999e52025-03-02T10:46:39ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-0101495226Validation of pharmaceutical information systems: general provisionsK. 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 FederationNternational practices comprise integrated common approaches to validation of information systems, used in pharmaceutical industry by various organizations and that affect the results of their work. The purpose ofvalidation is to assure that the results, obtained with the help of an information system are reliable. Validated system ensures accurate results and reduces the risk of errors. The article describes basic principles of the validation of pharmaceutical information systems. The principles are constituted on the basis of international requirements of OMCL system and international standards of ISO system. The article provides the classification information systems used in pharmaceutical organizations. It also describes basic concepts of validation of information systems, such as version management, validation testing, change management, requirement consideration. Basic requirements for application of risk management system to creation of concept devoted to pharmaceutical information system validation are also provided.https://www.vedomostincesmp.ru/jour/article/view/28валидацияинформационные системыинформатизация здравоохраненияавтоматизированные информационные системыvalidationinformation systemspublic health informationautomated information systemsvalidationinformation systemspublic health informationautomated information systems |
| spellingShingle | K. A. Koshechkin E. V. Gladkaya Ya. Yu. Kondratieva Validation of pharmaceutical information systems: general provisions Регуляторные исследования и экспертиза лекарственных средств валидация информационные системы информатизация здравоохранения автоматизированные информационные системы validation information systems public health information automated information systems validation information systems public health information automated information systems |
| title | Validation of pharmaceutical information systems: general provisions |
| title_full | Validation of pharmaceutical information systems: general provisions |
| title_fullStr | Validation of pharmaceutical information systems: general provisions |
| title_full_unstemmed | Validation of pharmaceutical information systems: general provisions |
| title_short | Validation of pharmaceutical information systems: general provisions |
| title_sort | validation of pharmaceutical information systems general provisions |
| topic | валидация информационные системы информатизация здравоохранения автоматизированные информационные системы validation information systems public health information automated information systems validation information systems public health information automated information systems |
| url | https://www.vedomostincesmp.ru/jour/article/view/28 |
| work_keys_str_mv | AT kakoshechkin validationofpharmaceuticalinformationsystemsgeneralprovisions AT evgladkaya validationofpharmaceuticalinformationsystemsgeneralprovisions AT yayukondratieva validationofpharmaceuticalinformationsystemsgeneralprovisions |