The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise

Authors

  • A. A. Fedoseeva

DOI:

https://doi.org/10.14739/2409-2932.2014.1.24945

Keywords:

Safety-Case document, software, pharmaceutical enterprise, technological process of manufacture, drug, ICS of critical used, safety

Abstract

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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How to Cite

1.
Fedoseeva AA. The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise. Current issues in pharmacy and medicine: science and practice [Internet]. 2014May23 [cited 2025Apr.30];(1). Available from: https://pharmed.zsmu.edu.ua/article/view/24945

Issue

No. 1 (2014)

Section

Proceedings of scientific conferences

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