Validation of pharmaceutical information systems: general provisions
Abstract
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.
About the Authors
K. A. Koshechkin
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
E. V. Gladkaya
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Ya. Yu. Kondratieva
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
References
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Review
For citations:
Koshechkin K.A., Gladkaya E.V., Kondratieva Ya.Yu. Validation of pharmaceutical information systems: general provisions. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(1):49-52. (In Russ.)
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