Questions and Answers on Audit Trail (Review) – Part 1
Requirements for an audit trail can be found in all relevant regulations. It is intended to ensure that changes to and deletions of data – and in future possibly also the creation of data – can be traced. In the current draft of EU GMP Guideline Annex 11, the requirements are described in significantly more detail than before. Six experts from the pharmaceutical industry and regulatory authorities answer an extensive catalogue of questions, which essentially refers to the Annex 11 currently still in force.
The Experts
- Klaus Feuerhelm, Regierungspräsidium Tübingen
- Eberhard Kwiatkowski, PharmAdvantageIT, Neuschoo
- Dr Ullrich Opitz, Merck, Darmstadt
- Yves Samson, Kereon, Basel
- Dr Wolfgang Schumacher, ehem. F. Hoffmann-La Roche, Basel
- Dr Arno Terhechte, Bezirksregierung Münster
Question 1: From the perspective of the regulations or the inspectors, are there any requirements as to what must, as a minimum, be included in an audit trail?
Indications regarding inspectors' expectations can be found in the EFG 11 aide-memoire "Überwachung computergestützter Systeme" ("Inspection of computerised systems"). This is a catalogue of requirements, questions and recommendations. The document is part of the quality system of the inspectorates in Germany. It serves to harmonise the preparation, conduct and follow-up of an inspection.
The minimum requirements regarding the content of an audit trail are set out in EU GMP Annex 11 and EU GMP Chapter 4. As a general rule, the following applies:
The following information should be included in the audit trail:
- Who changed "what, when and how"?
- Display of the original and the modified value
- Reason for the change/deletion
Question 2: Does the audit trail have to be printable?
As a general principle, everything in an audit trail must be capable of being printed. This follows from EU GMP Annex 11, section 8, "Printouts":
8.1 It should be possible to obtain clear printed copies of electronically stored data.
8.2 For records supporting batch release it should be possible to generate printouts indicating if any of the data has been changed since the original entry.
Question 3: Most equipment in QC is "off the shelf" and preconfigured. The audit trail cannot be configured or is preconfigured. How should this be handled?
If the audit trail cannot be configured, a risk assessment must first be carried out to determine whether it covers all essential requirements for this particular instrument. If this is not the case, another supplier should be chosen whose audit trail meets the requirements. If that is not possible, the only remaining last resort is to record the actions that are not covered manually in a logbook and in an appropriate SOP.
Question 4: Which events must be captured in the audit trail? Only GMP-relevant operator entries, or also technical failures of important components?
The audit trail should log all quality-critical data changes and operator interventions. Critical alarms and warnings that are acknowledged by the user and, where applicable, rectified by changing a parameter in the system must therefore also be logged. Pure notifications that are resolved by the system or equipment itself without user intervention belong in the alarm or deviation list and, where applicable, in the batch or investigation report.
Recommendation
29 September - 2 October 2026
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Question 5: Who defines the results relevant for the audit trail – the customer, the supplier, or both?
Both. Based on their knowledge of the system, the supplier can only specify the critical points known to them (in analytics this is usually already sufficient). For process-relevant points (for example in a PLS), the customer must check whether all relevant aspects of their manufacturing process have been adequately taken into account by the supplier and, where applicable, have the parameter settings changed.
Question 6: Confirmation of the audit trail review is given on screen. How does the QP check this at batch release, and is it needed for release?
First, the audit trail review must be defined in an SOP. The person carrying out the review should be, to some extent, independent of the business process. The review is documented. The review can form part of the batch record review.
Discrepancies in audit trails must be investigated and resolved, including escalation processes for notification (who has to be informed when). For release of a medicinal product by the QP, the decisive factor is the QP's assessment of the deviations. The product can then be released.
Question 7: Is a missing comment (reason for a change) in the audit trail already a reason for an observation during an inspection?
According to EU GMP Annex 11, changes or deletions must be justified. If the system is capable of this and no reason is entered, this constitutes a deficiency. If the system is not capable of documenting the reason, an appropriate workaround is needed. For systems without this functionality, an SOP can be used to define how changes or deletions are documented in a logbook.
Question 8: What are the expectations if an existing system has no audit trail or its audit trail does not meet the requirements? Must this system be replaced? And what if there is no replacement system that meets these requirements?
If an existing system has been developed and configured for a very specific application, a risk analysis should be carried out to determine which particular issues (could) exist with regard to data integrity. Based on this analysis, the batch-specific checks that are to be carried out instead of the audit trail review (ATR) must be defined.
Recommendation
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Question 9: Must an audit trail functionality be retrofitted to critical production machinery if, for example, it is already more than 20 years old and currently has no audit trail function?
This question cannot be answered in a general way. If process control is carried out using paper-based documentation followed by a batch record review, the authorities will not require costly replacement of the machine during an inspection. This also depends on the company's overall level of compliance and the general impression gained during the inspection.
This statement certainly does not apply to quality control, as in this area data falsification could be carried out relatively easily. QC systems should be upgraded or replaced by up-to-date applications in the short to medium term.
| Part 2 of the Q&As will be published in the next issue of the GMP Journal. |
About the Author
Dr Andreas Mangel organises and conducts courses and conferences for the ECA Academy in the areas of sterile production and computer validation.
