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...

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Bibliographic Details
Main Authors: K. A. Koshechkin, E. V. Gladkaya, Ya. Yu. Kondratieva
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
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/48
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