{"title":"制药企业MES软件需求分析","authors":"A. Fedoseeva, V. Kharchenko","doi":"10.1109/EWDTS.2014.7027090","DOIUrl":null,"url":null,"abstract":"Approach to safety assessment for manufacturing execution systems (MESs) of pharmaceutical enterprise based on the Safety Case methodology is proposed. Normative profile for MES software based on requirements of international standards, guidelines and technical reports of the pharmaceutical enterprise (PE) and general requirements to critical software is developed. The facet-hierarchical structure of requirements to the PE MES software is suggested.","PeriodicalId":272780,"journal":{"name":"Proceedings of IEEE East-West Design & Test Symposium (EWDTS 2014)","volume":"38 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2014-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Profiling of MES software requirements for the pharmaceutical enterprise\",\"authors\":\"A. Fedoseeva, V. Kharchenko\",\"doi\":\"10.1109/EWDTS.2014.7027090\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Approach to safety assessment for manufacturing execution systems (MESs) of pharmaceutical enterprise based on the Safety Case methodology is proposed. Normative profile for MES software based on requirements of international standards, guidelines and technical reports of the pharmaceutical enterprise (PE) and general requirements to critical software is developed. The facet-hierarchical structure of requirements to the PE MES software is suggested.\",\"PeriodicalId\":272780,\"journal\":{\"name\":\"Proceedings of IEEE East-West Design & Test Symposium (EWDTS 2014)\",\"volume\":\"38 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2014-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Proceedings of IEEE East-West Design & Test Symposium (EWDTS 2014)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1109/EWDTS.2014.7027090\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Proceedings of IEEE East-West Design & Test Symposium (EWDTS 2014)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1109/EWDTS.2014.7027090","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Profiling of MES software requirements for the pharmaceutical enterprise
Approach to safety assessment for manufacturing execution systems (MESs) of pharmaceutical enterprise based on the Safety Case methodology is proposed. Normative profile for MES software based on requirements of international standards, guidelines and technical reports of the pharmaceutical enterprise (PE) and general requirements to critical software is developed. The facet-hierarchical structure of requirements to the PE MES software is suggested.
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