How to Deal with Audit Trails in Preconfigured Equipment?

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 3: Most of the equipment in QC is ‘off the shelf’ and preconfigured. The audit trail cannot be adjusted or is preconfigured. How should this be handled?

If the audit trail cannot be configured, a risk assessment must first be carried out to check whether it covers all the essential requirements for this device. If this is not the case, another supplier should be chosen whose audit trail meets the requirements. If this is not possible, the only solution is to manually log the uncovered actions in a logbook and a corresponding SOP.

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