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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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
Subjects:
Online Access:http://pharmed.zsmu.edu.ua/article/view/24945/22379
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author A. A. Fedoseeva
author_facet A. A. Fedoseeva
author_sort A. A. Fedoseeva
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description 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.
format Article
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institution Kabale University
issn 2306-8094
2409-2932
language English
publishDate 2014-04-01
publisher Zaporizhzhia State Medical and Pharmaceutical University
record_format Article
series Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki
spelling doaj-art-fa625d82f7ef49a486847054ff0728eb2025-08-20T03:39:22ZengZaporizhzhia State Medical and Pharmaceutical UniversityAktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki2306-80942409-29322014-04-01111211310.14739/2409-2932.2014.1.24945The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterpriseA. A. FedoseevaThe 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.http://pharmed.zsmu.edu.ua/article/view/24945/22379Safety-Case documentsoftwarepharmaceutical enterprisetechnological process of manufacturedrugICS of critical usedsafety
spellingShingle A. A. Fedoseeva
The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki
Safety-Case document
software
pharmaceutical enterprise
technological process of manufacture
drug
ICS of critical used
safety
title The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
title_full The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
title_fullStr The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
title_full_unstemmed The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
title_short The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
title_sort use of safety case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise
topic Safety-Case document
software
pharmaceutical enterprise
technological process of manufacture
drug
ICS of critical used
safety
url http://pharmed.zsmu.edu.ua/article/view/24945/22379
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AT aafedoseeva useofsafetycasedocumentforevaluationandguaranteeofsecuritysoftwareandinformationtechnologyatthepharmaceuticalenterprise