The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
DOI:
https://doi.org/10.14739/2409-2932.2014.1.24945Keywords:
Safety-Case document, software, pharmaceutical enterprise, technological process of manufacture, drug, ICS of critical used, safetyAbstract
The Safety-Case methodology of provision and safety proof of ASC technological process of drugs’ manufacturing have been considered; standard items of Safety-Case document as an evidence of the functional safety of used control system automated process of drugs’ manufacturing at the pharmaceutical enterprise have been proposed.
References
Харченко В.С. Case-оценка критических программных систем: в 3 т. / В.С. Харченко, Е.И. Неткачева, А.А. Орехова и др. ; [под ред. В.С. Харченко]. – Х. : Нац. аэрокосмический ун-т «ХАИ», 2012. – Т. 3: Безопасность. – 301 с.
Вishop P. A Methodology for Safety Case Development [Text] / P. Bishop. – Springer-Verlag. – 1998. – February.
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