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 ...
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
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Computerized System Validation: Regulatory Compliance and Process Safety in the Pharmaceutical IndustryYves SamsonConference ERTS'06
The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The obj ective to do so is to clearly specify that each application of information technology ...
Validation of Computerized Systems - Robert Tollefsen
PDA Technical Report 18 on validation of computer-related systems that contains a more specific computer validation definition than the FDA process validation definition quoted in Section 3.1 of the GPG.5,6 AAPS Analytical Instrument Qualification white paper published in 2004, which was the outcome ...
2010版药品生产质量管理规范(GMP)附录《计算机化系统》的颁布,为我国制药行业计算机化系统的管理提出了要求.而其中计算机化系统验证的水平是国内药品生产企业的短板.基于《良好自动化生产实践指南(5版)》(GAMP5)这一国际通用的计算机化系统验证指南,本文以4类软件中最为复杂的SAP(即system applications and products)软...
Define computerized tomography. computerized tomography synonyms, computerized tomography pronunciation, computerized tomography translation, English dictionary definition of computerized tomography. n. Computed tomography. American Heritage® Dictiona
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...