{"title":"制药行业数据完整性的一种方法","authors":"","doi":"10.31838/ecb/2023.12.1.002","DOIUrl":null,"url":null,"abstract":": Data Integrity assures that the information is traceable, readable, current, unique, and correct. It is an essential aspect of the industry's obligation to assure the safety, efficacy, and quality of their products. In pharmaceutical industry it plays a vital role and it is an important current issue for regulators around the world. During inspections a multiple of problems being found by the pharmaceutical regulatory agency all over the world. There are many regulatory guidelines on data integrity. The objective of this study carries number of issues involved within data integrity in current GMP aspects, the root causes were addressed grounded on warning letters. In this article we study about types, advantage and disadvantage, factors affecting, ALCOA concept, and their limitations.","PeriodicalId":11880,"journal":{"name":"European Chemical Bulletin","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES\",\"authors\":\"\",\"doi\":\"10.31838/ecb/2023.12.1.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\": Data Integrity assures that the information is traceable, readable, current, unique, and correct. It is an essential aspect of the industry's obligation to assure the safety, efficacy, and quality of their products. In pharmaceutical industry it plays a vital role and it is an important current issue for regulators around the world. During inspections a multiple of problems being found by the pharmaceutical regulatory agency all over the world. There are many regulatory guidelines on data integrity. The objective of this study carries number of issues involved within data integrity in current GMP aspects, the root causes were addressed grounded on warning letters. In this article we study about types, advantage and disadvantage, factors affecting, ALCOA concept, and their limitations.\",\"PeriodicalId\":11880,\"journal\":{\"name\":\"European Chemical Bulletin\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Chemical Bulletin\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.31838/ecb/2023.12.1.002\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Chemistry\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Chemical Bulletin","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.31838/ecb/2023.12.1.002","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Chemistry","Score":null,"Total":0}
AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES
: Data Integrity assures that the information is traceable, readable, current, unique, and correct. It is an essential aspect of the industry's obligation to assure the safety, efficacy, and quality of their products. In pharmaceutical industry it plays a vital role and it is an important current issue for regulators around the world. During inspections a multiple of problems being found by the pharmaceutical regulatory agency all over the world. There are many regulatory guidelines on data integrity. The objective of this study carries number of issues involved within data integrity in current GMP aspects, the root causes were addressed grounded on warning letters. In this article we study about types, advantage and disadvantage, factors affecting, ALCOA concept, and their limitations.
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