基于数据的关键程度进行风险评估，按照风险的高、中、低制定审核策略，对于关键性的电子数据（产品放行相关）需要放行前完成审核，对于风险较低的数据可以采用适当放宽的审核策略；数据的审核按照层级进行审核，数据产生部门进行相关电子数据及审计追踪的审核，质量部门进行周期性的抽查。

关于数据的关键程度的评估可以参考PIC 数据完整性指南中的规定：数据对于决策的影响、数据对局产品质量或者病人安全性

Data criticality

The decision that data influences may differ in importance and the impact of the data to a decision may also vary. Points to consider regarding data criticality include:

Which decision does the data influence?

For example: when making a batch release decision, data which determines compliance with critical quality attributes is normally of greater importance than warehouse cleaning records.

What is the impact of the data to product quality or safety?

For example: for an oral tablet, API assay data is of generally greater impact to product quality and safety than tablet friability data.