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A Retrospective Validation Method for Drug Manufacturing Computerized System using Programmable Logic Controller

机译:使用可编程逻辑控制器的药物制造计算机化系统的回顾性验证方法

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This paper proposes Retrospective Validation method for working Programmable-Logic-Controller based Computerized System. The proposed method consists of three solutions; (1) clarify a validation concept for computerized system that is developed by combining several different categories, (2) Clarify risk reduction measures into four types (task, program, structure, and hardware modification), and (3) Define detailed RCSV procedure depending on the current status of PBCS and development documents. As a result of application, we found that the proposed method reduce the 20% working time and develop adequate validation documents.
机译:本文提出了基于工作的可编程逻辑控制器的追溯验证方法。所提出的方法包括三种解决方案; (1)澄清通过组合几种不同类别而开发的计算机化系统的验证概念,(2)将风险降低措施澄清为四种类型(任务,程序,结构和硬件修改),(3)定义详细的RCSV过程取决于论PBCS和开发文件的现状。由于申请的结果,我们发现所提出的方法减少了20%的工作时间并开发了足够的验证文件。

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