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What are the essential parts of an audit trail?

19/09/2021 | 889

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Reply:

An audit trail has to at least record the critical variables/values, indicate the initial value and the changed one, indicate who has changed what and when.
This includes a unique identification of the user, a date and time stamp as well as possibly a comment. What’s new pursuant to Annex 11 is the comment on the reason for change. Here it would be possible to restrict the number of parameters to be commented by using risk assessment.

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