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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:
某些數(shù)據(jù)術(shù)語(yǔ)應(yīng)該在SOP中進(jìn)行描述，并且還可以在SOP找到有關(guān)如何處理這些數(shù)據(jù)類型的說明。以下是一些基本的數(shù)據(jù)類型：

Raw data 原始數(shù)據(jù)
Source data 源數(shù)據(jù)
Critical data 關(guān)鍵數(shù)據(jù)

This means that we should also define these data types in an SOP for our operation.
這意味著我們還應(yīng)該在SOP中為我們的操作定義所屬的數(shù)據(jù)類型。

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，術(shù)語(yǔ)“關(guān)鍵數(shù)據(jù)”只出現(xiàn)在一個(gè)地方—歐盟GMP指南第4章，4.27：“應(yīng)該建立一個(gè)系統(tǒng)來指示特殊觀察結(jié)果和關(guān)鍵數(shù)據(jù)的任何變化。”

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."
歐盟GMP附錄11也只在一個(gè)地方提到了“關(guān)鍵數(shù)據(jù)”——附錄11，6：“準(zhǔn)確性檢查：對(duì)于手動(dòng)輸入的關(guān)鍵數(shù)據(jù)，應(yīng)該對(duì)數(shù)據(jù)的準(zhǔn)確性進(jìn)行額外檢查。”



So here we are talking about the modification of critical data and the correct entry of critical data into a computerised system.
所以我們?cè)谶@里討論的是關(guān)鍵數(shù)據(jù)的修改以及關(guān)鍵數(shù)據(jù)正確輸入計(jì)算機(jī)系統(tǒng)。

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."
我們?cè)贓U GMP中沒有找到關(guān)鍵數(shù)據(jù)的法律定義。這意味著我們應(yīng)該在SOP中定義這個(gè)術(shù)語(yǔ)。在這方面也有適當(dāng)?shù)闹笇?dǎo)。例如，在VDI/VDE 3516 Sheet 5 GxP環(huán)境中的驗(yàn)證—原始數(shù)據(jù)的類型中，我們發(fā)現(xiàn)以下定義:“關(guān)鍵數(shù)據(jù)：對(duì)患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性有潛在影響的數(shù)據(jù)。”

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) -監(jiān)測(cè)計(jì)算機(jī)化系統(tǒng)(僅德語(yǔ))中找到更多的信息。在這里，你可以找到以下問題的答案：

"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在評(píng)估中哪些數(shù)據(jù)需要被定義為關(guān)鍵數(shù)據(jù)?”哪些數(shù)據(jù)被認(rèn)為是關(guān)鍵的，應(yīng)該提前定義。原則上，如果需要跟蹤或評(píng)估GxP活動(dòng)，則數(shù)據(jù)和相關(guān)元數(shù)據(jù)是GMP關(guān)鍵數(shù)據(jù)。”

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:
從這一描述可以間接推斷，實(shí)際上沒有不重要的GMP相關(guān)數(shù)據(jù)。因此，這兩種描述的差別并非微不足道，因此產(chǎn)生了以下問題：

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.
有沒有不重要的與GMP相關(guān)的數(shù)據(jù)？實(shí)際上，可以假設(shè)GMP相關(guān)性也包含關(guān)鍵性，盡管程度不同。PIC/S PI 041和EMA關(guān)于數(shù)據(jù)完整性的問答確認(rèn)了這一點(diǎn)。

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.
根據(jù)PIC/S PI 041，并非所有數(shù)據(jù)對(duì)產(chǎn)品質(zhì)量和患者安全具有相同的意義。PIC/S PI 041在這里給出了示例。有關(guān)有效成分含量的數(shù)據(jù)比有關(guān)倉(cāng)庫(kù)清潔方案的數(shù)據(jù)更為關(guān)鍵。
EMA Q&A DATA INTEGRITY: "How can data criticality be assessed?
EMA Q&A數(shù)據(jù)可靠性:“如何評(píng)估數(shù)據(jù)的關(guān)鍵性?

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:
數(shù)據(jù)對(duì)決策的重要性和影響程度可能不同。關(guān)于數(shù)據(jù)的關(guān)鍵性需要考慮的要點(diǎn)包括：

What decision does the data influence?"
“數(shù)據(jù)會(huì)影響什么決策?”

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，我們可以定義不同的關(guān)鍵性水平，至少是關(guān)鍵和次關(guān)鍵。數(shù)據(jù)的重要性取決于數(shù)據(jù)的用途。例如，用于確定批次放行的數(shù)據(jù)當(dāng)然是至關(guān)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.
根據(jù)不同的關(guān)鍵程度對(duì)數(shù)據(jù)進(jìn)行分類是有意義的。例如，關(guān)于EU-GMP附錄11修訂的概念文件也指出了這一點(diǎn)。

"[6] Guidelines should be included for classification of critical data and critical systems."
“[6]指導(dǎo)文件中應(yīng)該要包含關(guān)鍵數(shù)據(jù)和關(guān)鍵系統(tǒng)的分類原則。”

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.
原則上，可以肯定地說，所有與GMP相關(guān)的數(shù)據(jù)都以不同的方式至關(guān)重要。決定性因素是數(shù)據(jù)是否與GMP相關(guān)。