EDQM发布新修订计算机系统验证指导原则-2018.04.09

Revised: “Validation of Computerised Systems” Guideline

European network of omcls general european omcls network activities

2018.04.09

Since the adoption of the first version of the “Validation of Computerised Systems” Guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.

The revised version is now organised in a core document and two annexes (instead of three annexes in the previous version). all three parts of the guideline will come into force on 1 August 2018.

自2009年5月份发布第一版计算机系统验证指导原则以来，大多数的网络成员都已经引进了计算机系统，例如在他们的实验室引进实验室信息管理系统（LIMS）以及电子文件管理系统，这已经成为网络中常用的工作工具。基于上述原因及相互联合审计中获得的经验，该指导原则已经被重新调整和修订。

修订版现在已经被组织在一个核心文件和两个附件中，这三个部分的指导文件从2018年8月1日开始强制实施。

) ]; {2 t- B6 h, ]# o