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 ...
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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
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 ...
A Proposal of Retrospective Validation for PLC-based Computerized System Considering GAMP5 This paper proposes a method to prove that working drug manufacturing computerized systems using Programmable Logic Controller (PLC) have adequate function... M Takahashi - 《Transactions of the Society of Instrumen...
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...
Technical validation of com- puterized condylographic system. Int J Stomat Occl Med 2008;1:1-6.Mantout B, Giraudeau A, Perez C, Re J-P, Orthlieb JD. Technical validation of a computerized condylographic system. J Stomat Occ Med 2008;1:45-50....
Computerized visual assessment and validation technique in an Integrated Agriculture-Aquaculture System (IAAS)Computerized visual assessment and validation technique in an Integrated Agriculture-Aquaculture System (IAAS)ValidationComputerized assessmentMacrobrachium rosenbergiiIntegrated culture systemRecirculating...
L. (2018) Computer-Based Neuropsychological Assessment: A Validation of Structured Examination of Executive Functions and Emotion. In: Harris D. (eds) Engineering Psychology and Cognitive Ergonomics. EPCE 2018. Lecture Notes in Computer Science, vol 10906. Springer, Cham. https://doi.org/10.1007...