The 10 references in paper K. Koschechkin A., E. Gladkaya V., Ya. Kondratieva Yu., К. Кошечкин А., Е. Гладкая В., Я. Кондратьева Ю. (2018) “Валидация фармацевтических информационных систем: вычислительное программное обеспечение и персональные компьютеры // Validation of pharmaceutical information systems: computer software and personal computers” / spz:neicon:vedomostincesmp:y:2015:i:2:p:45-48

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.
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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.
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3
General requirements for the competence of testing and calibration laboratories. State Standard ISO/MEK 17025-2009 (in Russian).
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4
Guidance for the management of computers and software in laboratories with reference to ISO/IEC 17025:2005 (Technical Report No 2/2006, October 2006, eurolab).
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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).
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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_calculation.pdf.
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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.
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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.
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9
Smith P (1 December 2008). 20th Anniversary Special Feature: Validation and qualification. Pharmaceutical Technology Europe 20 (2). Retrieved 28 February 2012.
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10
DeSpautz J, Kovacs KS, Werling G (11 March 2008). GAMP Standards For Validation Of Automated Systems. Pharmaceutical Processing. Retrieved 28 February 2012. R E F E R E N C E S Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Me-
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