{"title":"[计算机辅助生产血液和血液成分输血程序的验证]。","authors":"F Reinhardt","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The validation of computer-aided methods in the production of stored blood and blood components represents for a pharmaceutical institution a basic condition for the carrying out of the decrees of pharmaceutical companies. When validating computer-aided methods in medicine or pharmacy, the fields of informatics and technology have to be linked to applications in medicine and pharmacy.</p><p><strong>Method: </strong>In many cases the methods for the documented proof that a system achieves the expected capacity are too complex, so that a validation is only practicable in module groups. This is shown with an example of the blood typing on microtiter plates.</p><p><strong>Results: </strong>After the selection of the hard- and software according to the safety criteria of information technology taking into consideration functional classes and degrees of quality, a complete documentation of the validation of blood typing on the microtiter plate was carried out.</p>","PeriodicalId":13632,"journal":{"name":"Infusionstherapie und Transfusionsmedizin","volume":"22 3","pages":"196-9"},"PeriodicalIF":0.0000,"publicationDate":"1995-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Validation of a computer-assisted procedure for producing blood and blood component transfusions].\",\"authors\":\"F Reinhardt\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The validation of computer-aided methods in the production of stored blood and blood components represents for a pharmaceutical institution a basic condition for the carrying out of the decrees of pharmaceutical companies. When validating computer-aided methods in medicine or pharmacy, the fields of informatics and technology have to be linked to applications in medicine and pharmacy.</p><p><strong>Method: </strong>In many cases the methods for the documented proof that a system achieves the expected capacity are too complex, so that a validation is only practicable in module groups. This is shown with an example of the blood typing on microtiter plates.</p><p><strong>Results: </strong>After the selection of the hard- and software according to the safety criteria of information technology taking into consideration functional classes and degrees of quality, a complete documentation of the validation of blood typing on the microtiter plate was carried out.</p>\",\"PeriodicalId\":13632,\"journal\":{\"name\":\"Infusionstherapie und Transfusionsmedizin\",\"volume\":\"22 3\",\"pages\":\"196-9\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1995-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Infusionstherapie und Transfusionsmedizin\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Infusionstherapie und Transfusionsmedizin","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[Validation of a computer-assisted procedure for producing blood and blood component transfusions].
Background: The validation of computer-aided methods in the production of stored blood and blood components represents for a pharmaceutical institution a basic condition for the carrying out of the decrees of pharmaceutical companies. When validating computer-aided methods in medicine or pharmacy, the fields of informatics and technology have to be linked to applications in medicine and pharmacy.
Method: In many cases the methods for the documented proof that a system achieves the expected capacity are too complex, so that a validation is only practicable in module groups. This is shown with an example of the blood typing on microtiter plates.
Results: After the selection of the hard- and software according to the safety criteria of information technology taking into consideration functional classes and degrees of quality, a complete documentation of the validation of blood typing on the microtiter plate was carried out.