Safety Database - Audit Trail Review
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Is it necessary to periodically review the audit trails of the safety databases like Argus, ARISg etc?
If yes, then from what purview?
Strictly speaking and from a data integrity standpoint, I'd say yes nevertheless, I'd do this following a risk based approach e.g. at the time of specific audits, periodic review of the system, sampling, .. in order to ensure that the integrity of data is ensured.
Thanks Raquel. This is very useful. However, it will be great if you could suggest what exactly should we look for, while reviewing Audit trails? Should we review the history for ICSRs or only the admin rights related activities, or even case deletions?
Unlike GMP systems, safety databases work slightly differently as multiple personnel can process the same ICSR; this can even be the case for same workflow process (e.g. quality review).