GxP关键性评估工具的具体出处？

药白2021

各位老师，计算机系统的初步风险评估时，有用到GxP关键性评估工具，这个工具出自哪部法规？指南？或参考书？

小河马吃辣条

gamp5 附录3

sssff

GAMP5 M3附录
5.3.1.2 System Impact
The initial risk assessment should determine the overall impact that the computerized system may have on patient safety, product quality, and data integrity due to its role within the business processes. This should take into account both the complexity of the process, and the complexity, novelty, and use of the system. Categorization assists in assessing system complexity and novelty (see Appendix M4).
In general, high impact systems typically include those that:

• generate, manipulate, or control data supporting regulatory safety and efficacy submissions
• control critical parameters or data used at any stage, including pre-clinical, clinical, development, and manufacture
• control or provide data for product release
• control data required in case of product recall
• control adverse event or complaint recording or reporting
• support pharmacovigilance
  

Process knowledge assists with determining system impact (see Section 7.2 of this appendix for an example).
Systems that are of lower overall impact can be documented and tested less rigorously (see Section 5.7 of this appendix).

竹子开花1

gamp5 附录3（21年）确实有讲GXP评估，但楼主应该是指判断是否GXP系统的十个问题出处

药白2021

sssff 发表于 2023-9-8 10:13
GAMP5 M3附录
5.3.1.2 System Impact
The initial risk assessment should determine the overall impact ...

非常感谢，

药白2021

竹子开花1 发表于 2023-9-8 11:38
gamp5 附录3（21年）确实有讲GXP评估，但楼主应该是指判断是否GXP系统的十个问题出处

是的，应该在GAMP5里面

sssff

竹子开花1 发表于 2023-9-8 11:38
gamp5 附录3（21年）确实有讲GXP评估，但楼主应该是指判断是否GXP系统的十个问题出处

GxP的系统影响性评估一般还是参考GAMP5了，不过只评判GMP的话确实GMP指南-质量管理体系中也有写，在3.6.5.4计算机化系统的GMP相关性评估这一节下