Current Questions and Answers on Data Integrity and Audit Trail Review

The evaluation of data with regard to criticality is essential and - to some extent - no trivial activity. Data must be evaluated in particular with regard to patient safety and/or product quality.

The term "critical data" appears at only one place in the EU GMP Guidelines:

"4.27 - A system should be in place to indicate special observations and any changes to critical data."

The EU GMP Annex 11 also mentions critical data at only one place.

"6. Accuracy Checks - For critical data entered manually, there should be an additional check on the accuracy of the data."

This provides a legal basis for reviewing the entry of critical data. A second person must therefore verify it. An alternative would be a validated computerised system.

The temperature is measured in a stirring tank. This measurement is part of the batch report and is relevant for release. The temperature is read manually and documented manually. In this case, a second person is required to check the correctness of the data (double-checking principle).


The temperature is recorded electronically via a computerised system and saved electronically. In this case, the computerised system would have to be validated.

Back to the evaluation of data criticality: neither section 4.27 nor Annex 11 (section 6) provides much information about which data is critical and which is not. There is no legal definition of critical data in the GMP environment. If one looks at the various guidelines and standards in the GMP area, a definition for critical data can be found in VDI/VDE 3516 Part 5 on "Validation in the GxP environment - Types of raw data":

"Critical data:
Data that has a potential impact on patient safety, product quality and data integrity".

It is the decision of the company (medicinal products manufacturer) to define the data to be included.

The crucial question is certainly: Is there any GMP-relevant data which is not critical?

This cannot be answered unequivocally from the contents of the current legal bases. However, the answer "No" is the productive one. Yet, there are differences in the criticality of data. Figure 1 shows a corresponding example. A three-level classification makes sense:

Criticality is high, medium or low.

PI 041 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS provides information on critical data, which also proves their significance.

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

The document stresses the importance of data in terms of its influence on decisions such as the batch release.

"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 is normally of greater importance than warehouse cleaning records"

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