Validation of pharmaceutical information systems: computer software and personal computers
Abstract
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.
Keywords
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
About the Authors
K. A. Koschechkin
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
1. OMCL guideline on Validation of computerised systems. Core document (PA/PH/OMCL (08) 69). Available from: https://www.edqm.eu/medias/fichiers/Validation_of_Computerised_Systems_Core_Document.pdf.
2. ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP). International Society for Pharmaceutical Engineering. 25 September 2011. Retrieved 28 February 2012.
3. General requirements for the competence of testing and calibration laboratories. State Standard ISO/MEK 17025-2009 (in Russian).
4. Guidance for the management of computers and software in laboratories with reference to ISO/IEC 17025:2005 (Technical Report № 2/2006, October 2006, eurolab).
5. Merkulov VA, Sakaeva IV, Koshechkin KA, et al. The experience in establishing Quality Management System in laboratories as exemplified by introducing Laboratory Information System. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2012; (4): 11–18 (in Russian).
6. Validation of computerised calculation Systems: example of validation of inhouse software PA/PH/OMCL (08) 87 2R. Available from: https://www.edqm.eu/medias/fichiers/NEW_Annex_1_Validation_of_computerised_calculati on.pdf.
7. Validation of databases (db), laboratory Information management systems (lims) and Electronic laboratory notebooks (eln). Available from: https://www.edqm.eu/medias/fichiers/NEW_Annex_2_Validation_of_Databases_DB_Laboratory_.pdf.
8. Validation of computers as part of test Equipment. Available from: https://www.edqm.eu/medias/fichiers/NEW_Annex_3_Validation_of_computers_as_part_of_tes.pdf.
9. Smith P (1 December 2008). 20th Anniversary Special Feature: Validation and qualification. Pharmaceutical Technology Europe 20 (2). Retrieved 28 February 2012.
10. DeSpautz J, Kovacs KS, Werling G (11 March 2008). GAMP Standards For Validation Of Automated Systems. Pharmaceutical Processing. Retrieved 28 February 2012.
Review
For citations:
Koschechkin K.A., Gladkaya E.V., Kondratieva Ya.Yu. Validation of pharmaceutical information systems: computer software and personal computers. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(2):45-48. (In Russ.)
Views:
652
Email this article 