Setpoint Changes and 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 19: If setpoint changes are provided for in the batch record and verified there via four-eyes principle, can a risk-based approach be used to waive the audit trail review in a process control system for these changes?

No. The changes — even if they are planned/authorized — should be documented in a traceable manner. The audit trail is the appropriate tool to ensure data integrity and to enable verification of who made the change, what was changed, when it was changed, and (where applicable) why it was changed.

Question 20: If the audit trail review (ATR) is performed electronically, can the result be documented on paper? Or should this also be done electronically?

To avoid a hybrid solution, the result should also be documented electronically. Paper documentation should be avoided, but it is not prohibited.

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