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

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 e...

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Bibliographic Details
Main Author: A. A. Fedoseeva
Format: Article
Language:English
Published: Zaporizhzhia State Medical and Pharmaceutical University 2014-04-01
Series:Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki
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Online Access:http://pharmed.zsmu.edu.ua/article/view/24945/22379
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Summary: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.
ISSN:2306-8094
2409-2932