ISPE 调试和确认(第二版)全文解读.PPT
2019年6月,ISPE发布基准指南5:调试和确认 第二版。
本次改版变动较前版(第一版)变动较大,其旨在提供一种兼容的、集成的C&Q方法,以使确认过程高效和经济有效。该方法包括一个系统风险评估过程(SRA),该过程识别关键方面和关键设计元素。
为此小智对该指南进行了解读,并形成该文章,包括新的系统影响评估的8个问题,如何进行系统风险评估SRA等内容。
本指南旨在提供一种兼容的、集成的C&Q方法,以使确认过程高效和经济有效。包括系统风险评估(SRA)、识别关键方面(CAs)和关键设计元素(CDEs)。提供最佳行业指南,以满足监管要求。提到URS、DQ/DR、IQ、OQ、PQ,还包括FAT/SAT、风险评估及案例等内容。
背景:ASTME2500-2013中也提到了调试过程,并将质量体系单元往前提,即提前到工程调试阶段,形成新的调试模式或者说确认模式。ISPE 调试和确认指南根据最近行业内的动态形成了该第二版指南。解读PPT如下:
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