Basically, certain data terms should be described in an SOP, and here you should also find instructions on how to deal with these data types. Essentially, these are the following data types:
某些数据术语应该在SOP中进行描述，并且还可以在SOP找到有关如何处理这些数据类型的说明。以下是一些基本的数据类型：

Raw data 原始数据
Source data 源数据
Critical data 关键数据

This means that we should also define these data types in an SOP for our operation.
这意味着我们还应该在SOP中为我们的操作定义所属的数据类型。

In the GMP Guidance, the term critical data only appears in one place - EU GMP Guidance Chapter 4, 4.27 ..."A system should be in place to indicate special observations and any changes to critical data."
在GMP指南中，术语“关键数据”只出现在一个地方—欧盟GMP指南第4章，4.27：“应该建立一个系统来指示特殊观察结果和关键数据的任何变化。”

The EU GMP Annex 11 also mentions "critical data" only in one place - Annex 11, 6."Accuracy Checks: For critical data entered manually, there should be an additional check on the accuracy of the data."
欧盟GMP附录11也只在一个地方提到了“关键数据”——附录11，6：“准确性检查：对于手动输入的关键数据，应该对数据的准确性进行额外检查。”



So here we are talking about the modification of critical data and the correct entry of critical data into a computerised system.
所以我们在这里讨论的是关键数据的修改以及关键数据正确输入计算机系统。

We do not find a legal definition of critical data in EU GMP. This means that we should define the term in an SOP. There is also appropriate guidance on this. For example, in VDI/VDE 3516 Sheet 5 Validation in the GxP environment - Types of raw data, we find the following definition:"Critical data: Data that have a potential impact on patient safety, product quality and data integrity."
我们在EU GMP中没有找到关键数据的法律定义。这意味着我们应该在SOP中定义这个术语。在这方面也有适当的指导。例如，在VDI/VDE 3516 Sheet 5 GxP环境中的验证—原始数据的类型中，我们发现以下定义:“关键数据：对患者安全、产品质量和数据完整性有潜在影响的数据。”

Further assistance can be found inEFG 11's AiM (Aide-Mémoire) - Monitoring Computerised Systems (only German). Here one can find the following question with answer:
也可以在EFG 11的AiM (aid - msammoire) -监测计算机化系统(仅德语)中找到更多的信息。在这里，你可以找到以下问题的答案：

"6-1 What data has been defined as critical in an assessment? Which data are to be considered critical should be defined in advance. In principle, data and the associated metadata are GMP-critical if they are needed to trace or assess a GxP activity."
“6-1在评估中哪些数据需要被定义为关键数据?”哪些数据被认为是关键的，应该提前定义。原则上，如果需要跟踪或评估GxP活动，则数据和相关元数据是GMP关键数据。”

From this description it can be indirectly inferred that there are actually no GMP-relevant data that are not critical. Both descriptions are therefore not insignificantly different and the question thus arises:
从这一描述可以间接推断，实际上没有不重要的GMP相关数据。因此，这两种描述的差别并非微不足道，因此产生了以下问题：

Are there any GMP-relevant data at all that are not critical? It can actually be assumed that GMP relevance also entails criticality, albeit to different degrees. This is confirmed by references in PIC/S PI 041 and the EMA Q&A on data integrity.
有没有不重要的与GMP相关的数据？实际上，可以假设GMP相关性也包含关键性，尽管程度不同。PIC/S PI 041和EMA关于数据完整性的问答确认了这一点。

According to PIC/S PI 041, not all data have the same significance for product quality and patient safety. PIC/S PI 041 gives examples here. The data on the active ingredient content is more critical than the data on the cleaning protocol for the warehouse.
根据PIC/S PI 041，并非所有数据对产品质量和患者安全具有相同的意义。PIC/S PI 041在这里给出了示例。有关有效成分含量的数据比有关仓库清洁方案的数据更为关键。
EMA Q&A DATA INTEGRITY: "How can data criticality be assessed?
EMA Q&A数据可靠性:“如何评估数据的关键性?

The decision which 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:
数据对决策的重要性和影响程度可能不同。关于数据的关键性需要考虑的要点包括：

What decision does the data influence?"
“数据会影响什么决策?”

Accordingly, we can define different levels of criticality, at least critical and less critical. The criticality of data depends on what the data is used for. For example, data used to determine batch release decisions is certainly critical.
因此，我们可以定义不同的关键性水平，至少是关键和次关键。数据的重要性取决于数据的用途。例如，用于确定批次放行的数据当然是至关重要的。

Classifying data according to different criticality can make sense. This is also indicated, for example, in the concept paper on the amendment of EU-GMP Annex 11.
根据不同的关键程度对数据进行分类是有意义的。例如，关于EU-GMP附录11修订的概念文件也指出了这一点。

"[6] Guidelines should be included for classification of critical data and critical systems."
“[6]指导文件中应该要包含关键数据和关键系统的分类原则。”

In principle, it can certainly be stated that all GMP-relevant data are critical in different ways. The decisive factor is whether data are GMP-relevant or not.
原则上，可以肯定地说，所有与GMP相关的数据都以不同的方式至关重要。决定性因素是数据是否与GMP相关。