精选计算机化系统验证ComputerizedSystemValidation.PDF,计算机化系统验证 Computerized System Validation 陈国笋Brant Chen 上海朗脉Macroprocess 计算机化系统的分类 1 Category of Computerized system 2 制药企业的计算机化系统 Computerized System in Pharmaceutical
内容提示: 计算机化系统验证Computerized System Validation笋 陈国笋 Brant Chen脉 上海朗脉 Macroprocess 文档格式:PDF | 页数:38 | 浏览次数:133 | 上传日期:2017-09-17 22:55:54 | 文档星级: 计算机化系统验证Computerized System Validation笋 陈国笋 Brant Chen脉 上海朗脉 Macroprocess ...
Computerized system validationRegulatory complianceSystem life cycleRisk managementTestingGAMPOne of the major concerns of the pharmaceutical industry is the importance of the regulations which have to be fulfilled. These establish various requirements for processes and associated systems without defining the ...
A validated process would require that a uniquely identifiable document is proofed. Because digitally produced documents are frequently still processed manually, the system does not comply with validation guidelines and QA requirements. Many companies still use manual processes because, until recently, appr...
Installation and operational qualification are important steps in the overall validation process of computerized analytical equipment. This article guides users of such systems step by step through the installation and operational qualification procedures. Guidelines address how to select the test items and ...
The publication of version 2 of these guidelines reflects the enormous contibution made by the International Society of Blood Transfusion Working Party on ... V Sanguinis 被引量: 0发表: 2009年 Computer System Validation for Life Science Industry q Introduction to Process Validationq Fundamental conce...
Computerized system validation 青云英语翻译 请在下面的文本框内输入文字,然后点击开始翻译按钮进行翻译,如果您看不到结果,请重新翻译! 翻译结果1翻译结果2翻译结果3翻译结果4翻译结果5 翻译结果1复制译文编辑译文朗读译文返回顶部 翻译结果2复制译文编辑译文朗读译文返回顶部...
The computerized system development and validation strategies described are useful for other applications in which numbers are interpreted in a narrative report format.doi:10.1111/j.1744-6570.1986.tb00951.xC. DAVID VALEAssessment Systems CorporationLAURA S. KELLER...
The monitoring system was validated using the 28 feeding places and 51 lactating cows. Cows were kept in the research facility of IRTA-Unitat de Remugants, located in Girona, Spain, and were managed under the supervision and guidelines of the Animal Care Committee of IRTA. Cows were fed a ...
Given this controversy, various testing guidelines published on computerized testing may be used to investigate the interchangeability of CFLT and PPBT mean scores to corroborate if test takers’ testing performance is influenced by the effects of testing administration mode; specifically, if validity ...