Dealing with Systems without Audit Trail Functionality

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 8: What are the expectations if an existing system does not have an audit trail or if it does not meet the requirements? Does this system need to be replaced? And what if there is no replacement system that meets these requirements?

If an existing system has been developed and configured for a very specific application, a risk analysis should be carried out to determine which specific problems (could) exist with regard to data integrity. Based on this analysis, batch-specific checks must be defined to be carried out instead of the ATR.

Question 9: Does an audit trail functionality have to be retrofitted to critical production equipment if, for example, they are already over 20 years old and currently have no audit trail function?

There is no general answer to this question: If process control is carried out using paper-based documentation with subsequent batch protocol review, the authorities will not demand a costly replacement of the machine during an inspection. This also depends on the general compliance of the company and the overall impression made during the inspection.
This statement certainly does not apply to quality control, as data falsification could be relatively easy in this area. QC systems should be upgraded/replaced with current applications in the short to medium term.

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