Content of an Audit Trail / Must an Audit Trail be printable?

The requirements for an audit trail can be found in all relevant regulations. The changes and deletions of data, and in future perhaps 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 1: From the regulators' or inspectors' point of view, is there a minimum requirement for what must be included in an audit trail?

Information regarding the expectations of the inspectors can be found in the Aide Memoire 'Supervision of Computerised Systems' of the EFG 11 (only as a German version available), which is a catalogue of guidelines, questions and recommendations. The document is part of the QA system of the inspectorates in Germany. It serves to harmonise the preparation, implementation 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:

The following information should be included in an audit trail:

• 'Who changed what, when and how?'
• Original and the changed value
• Reason for the change / deletion

Question 2: Does the audit trail have to be printable?

Everything must always be printable. This results from EU GMP Guide Annex 11: 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.

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