Executing 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 are described in much greater detail than before. Six 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 13: How is the audit trail review generally carried out: ‘manually’ by an employee or electronically supported?

The practice of audit trail review varies greatly: in laboratories, a specific checklist is usually used, which is then commented on and signed by the reviewer. It is important that this checklist identifies all data fields to be reviewed in order to ensure a complete review. It is advisable to carry out the review on screen to avoid time-consuming printing and subsequent storage/archiving of the documentation. The implementation of the audit trail review (responsibility, frequency, documentation) must be specified in an SOP.

Question 14: Is the four-eyes principle always necessary for the audit trail review? Production and QA review or QA review and releasing person?

The audit trail review is normally carried out by one person; a second employee to check the reviewer does not need to be involved in the review. For example, a production employee reviews the audit trail of the production data, and the same procedure is followed in quality control. The involvement of quality assurance (QA) is not necessary. The documentation of the audit trail review (completed and evaluated checklist) is sent to the qualified person (QP), who reviews the result with regard to batch release.

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