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Academic Journal
Validation of pharmaceutical information systems: computer software and personal computers
K. A. Koschechkin, E. V. Gladkaya, Ya. Yu. Kondratieva
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 45-48 (2018)
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| Title | Validation of pharmaceutical information systems: computer software and personal computers |
|---|---|
| Authors | K. A. Koschechkin, E. V. Gladkaya, Ya. Yu. Kondratieva |
| Publication Year |
2018
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| Source |
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 45-48 (2018)
|
| Description |
The article describes common principles for the validation of computer information systems and personal computers used as a basis for pharmaceutical information systems. The principles are elaborated in accordance with OMCL Network international requirements and international ISO standards. The article also provides classification used for information systems in pharmaceutical organizations. It describes common concepts for the validation of information systems: version management, validation testing, change management, requirements traceability. Common requirements for the use of risk management system for the purpose of development are also provided.
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| Document Type |
article
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| Language |
Russian
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| Publisher Information |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), 2018.
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| Subject Terms |
валидация, информационные системы, информатизация здравоохранения, автоматизированные информационные системы, вычислительные информационные системы, персональный компьютер, validation, information systems, informatization of public health, automatic information system, computational information systems, personal computer, Medicine (General), R5-920
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