在多个数据完整性指南和官方GMP问答中明确列出了数据关键程度的评估原则，以下是相关内容汇总，供参考：

WHO Guidance on good data and record management practices

Critical GXP：data with a direct impact on patient safety or product quality

关键数据：数据直接影响到病人的安全或最终产品的质量。

Medicines & Healthcare products Regulatory Agency (MHRA)‘GXP’ Data Integrity     Guidance and Definitions

4. Establishing data criticality and inherent integrity risk

4.1 Data has varying importance to quality, safety and efficacy decisions. Data criticality may be determined by considering how the data is used to influence the decisions made.

数据关键性及数据完整性风险

数据对于药品质量、安全及有效性的影响存在差异，数据的关键程度可以通过对于相关决策的影响程度来判定。

PICS GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS/ EU GMP DT Q&As

5.4 Data criticality

5.4.1 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 isnormally 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.

数据的关键性

数据对于决策的影响与数据的重要性有关，数据对于决策的影响也存在差异，数据关键性的考虑点如下：

数据影响到什么决策？

例如：放行决策，影响到关键质量属性的测试要比仓库清洁记录重要。

对于产品质量和安全性的影响

例如：口服片剂，API含量检测数据要比片剂的松脆度关键。

EMA guidance on good manufacturing practice and good distribution practice questions and answers

How can data criticality be assessed?

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 isnormally 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 dimensions data.

数据的关键性

数据对于决策的影响与数据的重要性有关，数据对于决策的影响也存在差异，数据关键性的考虑点如下：

数据影响到什么决策？

例如：放行决策，影响到关键质量属性的测试要比仓库清洁记录重要。

对于产品质量和安全性的影响

例如：口服片剂，API含量检测数据要比片剂的尺寸关键。

APIC Practical risk-based guide for managing Data Integrity

Data severity assessment: within CGxP data, different levels of severity can be defined as a function of its use. Typically, this is linked to the stage of manufacturing following the principle of increasing CGxP outlined in ICH Q7. Alternatively, other factors such as impact on final product quality can be taken into account to further differentiate between severity categories.

数据关键程度的评估应基于生产的步骤及对于最终产品质量的影响