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本帖最后由 vabs(李) 于 2020-2-12 22:59 编辑
5.6.2 Process, Process, Process5.6.2一定要注重过程(敲黑板)
One of the items not covered in Figure 5.4 is the understanding of the chromatographic process and how it can be redesigned using the introduction of a new version of an existing CDS or a completely new CDS to make the business process more efficient. Typically, this would be undertaken to use electronic signatures and electronic working with the elimination (or perhaps extermination would be a better word) of all those horrible spreadsheets that slow down the process. An organisation can spend a large amount of money on a shiny CDS that is capable of amazing things only for idiots in the laboratory to print out piles of paper then enter manually data into a spreadsheet and carefully check the entries. Perhaps if Dante were to rewrite his Inferno and set it in modern times, this would be his vision of chromatographic hell.Endless manual data entry and transcription error checks carried out for ever in an ocean of paper. This would be coupled with the devils from Hell’s QA department poking those miscreants who did not spot a transcription error with sharpened poles into places poles should not be poked into. Perhaps this is a description of your laboratory?
图5.4中没有涉及的内容之一是对色谱过程的理解,以及如何通过引入现有CDS的新版本或全新CDS来重新设计色谱过程,从而提高业务流程的效率。通常,这将被用于使用电子签名和电子工作与消除(或也许灭绝是一个更好的词)所有那些可怕的电子表格的工作减慢了进程。一个组织可以花大量的钱在高大上的CDS上,只有在实验室里的白痴才能打印出成堆的纸,然后手工输入数据到电子表格中,仔细检查条目。也许如果但丁重写他的《地狱》(但丁诗歌《神曲》三部曲:地狱、炼狱、天堂),把它放在现代,这就是他对色谱地狱的想象。无休止的手工数据输入和转录错误检查永远在纸的海洋中进行。与此同时,来自地狱的质量保证部门的魔鬼将那些没有发现抄写错误的恶棍用削尖了的杆子戳进了不该戳的地方。也许这是对你们实验室的描述?
In an ideal world we would be working electronically, the way this is achieved is to redesign the process as shown in Figure 5.5. The process is redesigned and the CDS application configured to match it. The focus as shown in Figure 5.5 is on a top down approach aimed at the process efficiency. Therefore, the validation of a CDS couples the life cycle tasks outlined in Figure 5.4 with the process redesign shown in Figure 5.5. Now the system is validated! We can now relax safe in the knowledge that things are under control.
在一个理想的世界中,我们将采用电子方式工作,实现这一点的方法是重新设计流程,如图5.5所示。重新设计了流程,并将CDS应用程序配置为与之匹配。如图5.5所示,重点是针对流程效率的自顶向下的方法。因此,CDS的验证将图5.4中概述的生命周期任务与图5.5中显示的流程重新设计相结合。现在系统已经过验证!我们现在可以放心地相信一切都在掌握之中。
老先生,你真是老顽童 
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