药厂计算机软件分级管理,药厂计算机系统验证(中英文)

Incident Management

Incidents can be classified using a severity scale 1, 2, 3

1 is minor –printing problem, insufficient details in the protocol, error in the protocol

2 is moderate –test may or may not meet acceptance criteria. However, this does not affect the use.

3 is major –test does not meet acceptance criteria and there is no work around.

偶发事件管理

偶发事件可以按照严重级别1、2、3来分级。

1 代表次要级–打印问题、方案中的不详尽之处、方案中的误差

2 代表中等级–测试未满足接受标准，但是，这不影响使用。

3 代表重大级–测试未满足接受标准，无法进行工作。

Incident Report

Incident management plan Incident report template

Incident log

偶发事件报告

偶发事件管理计划

偶发事件报告样本

偶发事件登录