Responsibilities for the Audit Trail (Review)

The requirements for an audit trail can be found in all relevant regulations. The changes and deletions of data, and in future also the creation of data, should be tracked in this way. In the new draft of the EU GMP guideline Annex 11, the requirements were described in much greater detail than before. 6 Experts from the pharmaceutical industry and from inspectorates answer an extensive list of questions in this context, focusing on the currently valid Annex 11.

Question 10: Who is the process owner for the audit trail review? QA or the system owner?

The audit trail is normally reviewed by the department that generated the data (e.g. in QC or production), but not by the same person who generated the data, i.e. by a colleague (peer review). The FDA's first Data Integrity Guidance still mentioned the Quality Unit (quality assurance) for this purpose; however, this was later changed to stipulate that a review must be carried out by a function with specialist knowledge. This view is also shared by all other guidelines.

Question 11: Who is responsible for creating the specific audit trail review SOP? The process owner (e.g. the plant) or QA, and who must create an SOP for the general framework conditions of the audit trail review?

To perform the audit trail review, an SOP is first required in which the risk assessment, the responsibilities for implementation and its frequency for the company are defined. This general SOP is usually created by the quality assurance department.
To perform the audit trail review in a specific computer system (e.g. chromatography data system CDS), the data fields to be checked must be defined in a checklist. This checklist is developed by the specialist department that operates the system.

Find more Q&As on the topic 'Audit Trail' which have been answered by the expert team.

The Expert Team:

Klaus Feuerhelm, Local GMP Inspectorate / 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, Local GMP Inspectorate / Bezirksregierung Münster