Audit Trail: No Option to Add Comments

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 17: If the system does not provide the option for the operator to add a comment when changing a parameter, how can this issue be addressed?

If an electronic system does not allow entries/comments to be recorded for parameter changes, the documentation must be performed manually on paper. This documentation must then be reviewed together with the rest of the batch record — including any electronic parts of the batch record, where applicable.

Question 18: Do adjustments and/or repairs to the underlying SQL database performed by the vendor/manufacturer also need to be captured in the audit trail — analogous to equipment repairs that are recorded in a logbook?

For programming activities/changes/updates/patches to a database, the Change Control process must be applied; it is irrelevant who performs these changes. An audit trail entry is not required.

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