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 ...
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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
Computerized System Validation: Regulatory Compliance and Process Safety in the Pharmaceutical IndustryYves SamsonConference ERTS'06
Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analy... C Press - 《Crc Press》 被引量: 15发表: 1995年 Testing and validation of computerized decision support systems. Systematic, through testing of ...
A computerized system should be thoroughly tested before it is used. If a manual system is replaced, the two should be run in parallel for a time as part of the testing and validation procedure. Data should only be entered or amended by authorized persons, and suitable methods of ...
Key words: computerized system; validation; clinical research 计算机化系统已广泛应用于临床试验的各个阶 全性已成为至关重要的问题。验证过程就是以文件化 段, 但如何证明计算机化系统的稳定性、可靠性和安 的证据来证实一个计算机化系统符 技术规范、达到 了设计要求并满足用户需求。系统验证不是静态的, 收稿...
Validation of Computerized Systems - Robert Tollefsen
作者: Matsuzawa,Toshiaki,Mukaiyama,Hidetaka 摘要: CiNii Articles - Computerized Systems Validation Measures (FDA 21CFR Part 11) on Drug Development (SEMINAR: COMPUTERIZED SYSTEMS VALIDATION (FDA21 CFR PART11) ON DRUG DEVELOPMENT) (Proceedings of the 30th Annual Meeting) 年份: 2003 收藏...
Sequential De-Bottlenecking of Organic Food Chains: A System-Dynamical Approach to Growth Design In general, models are interesting not so much because of their 'recommendations' or predictions, but because they can help identify the circumstances unde... Hans Schepers - International Conference on ...