Good Automated Manufacturing Practice. 1.0 BACKGROUND After over 4 years of re-work the GAMP Guide has been reissued at version 5. Gamp 5 is a major rewrite of the document and also has some significant changes in approach. These changes are to bring the procedure in line with the ...
内容提示: GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1 Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful? In the first part, I present an overview of the Guide, different approach ...
gamp good practice guide for validation of laboratory computerized systems 热度: ValidationofAutomationSystems GAMP5 1PharmaBioSolutionsLtd DifferentTerminology不同的术语 ,ComputerisedSystems计算机系统 ,AutomationSystems自动化系统 ,ControlSystems控制系统
a不好意思打扰一下 正在翻译,请等待... [translate] aGAMP? Good Practice Guide: Validation of Process Control GAMP ? 很好的练习指南: 检验程序控制 [translate] 英语翻译 日语翻译 韩语翻译 德语翻译 法语翻译 俄语翻译 阿拉伯语翻译 西班牙语翻译 葡萄牙语翻译 意大利语翻译 荷兰语翻译 瑞典语翻译 希腊语...
GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1 Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful In the first part, I present an overview of the Guide, different approach to life cycle...
GAMPGoodPracticeGuideforValidationofLaboratoryComputerizedSystems,Part1 Guidancetohelpvalidationofcomputerizedsystemsusedwithinregulatedlaboratoriesisalwayswelcomebutisitalwayshelpful?Inthefirstpart,IpresentanoverviewoftheGuide,differentapproachtolifecyclevalidationandsystemclassification. OverthepastyearsIhavenotspokeninanygre...
GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems
GAMP Good Practice Guide 作者: ISPE (COR) 出版社: Ispe Headquarters定价: 215装帧: PapISBN: 9781931879422豆瓣评分 目前无人评价 评价: 写笔记 写书评 加入购书单 分享到 推荐 我来说两句 短评 ··· ( 全部1 条 ) 热门 0 有用 镜Marvin 2013-03-08 11:43:22 参与极少部分的翻译。和写书的...
GAMP Good Practice Guide:Validation of Laboratory Computerized SystemsPreface to the GAMP Good PracticeGuide: Validation of LaboratoryComputerized SystemsPage 1This document, the GAMP Good Practice Guide: Validation of Laboratory Computeri~ed Systems, is intended as asupplement to Guide for Validation of...
The ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) applies a structured approach, including risk management, to the qualification, management, and control of IT Infrastructure platforms. It also offers a scalable framework which can be applied to different plat...