{"title":"CSA:无事生非?","authors":"R. Mcdowall","doi":"10.56530/spectroscopy.hm6969t6","DOIUrl":null,"url":null,"abstract":"Computerized system validation (CSV) in good practice (GxP)-regulated laboratories is alleged to take ages and generate piles of paper to keep inspectors and auditors quiet. To the rescue is the draft FDA guidance on computer software assurance (CSA). But...is this really the case?","PeriodicalId":21957,"journal":{"name":"Spectroscopy","volume":"24 1","pages":""},"PeriodicalIF":0.8000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"CSA: Much Ado About Nothing?\",\"authors\":\"R. Mcdowall\",\"doi\":\"10.56530/spectroscopy.hm6969t6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Computerized system validation (CSV) in good practice (GxP)-regulated laboratories is alleged to take ages and generate piles of paper to keep inspectors and auditors quiet. To the rescue is the draft FDA guidance on computer software assurance (CSA). But...is this really the case?\",\"PeriodicalId\":21957,\"journal\":{\"name\":\"Spectroscopy\",\"volume\":\"24 1\",\"pages\":\"\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2023-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Spectroscopy\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://doi.org/10.56530/spectroscopy.hm6969t6\",\"RegionNum\":4,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"SPECTROSCOPY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Spectroscopy","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.56530/spectroscopy.hm6969t6","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"SPECTROSCOPY","Score":null,"Total":0}
Computerized system validation (CSV) in good practice (GxP)-regulated laboratories is alleged to take ages and generate piles of paper to keep inspectors and auditors quiet. To the rescue is the draft FDA guidance on computer software assurance (CSA). But...is this really the case?
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