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Safety Database - Audit Trail Review

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  • Manoj Swaminathan
    09/10/2019 05:35
    Is it necessary to periodically review the audit trails of the safety databases like Argus, ARISg etc? If yes, then from what purview?
  • Raquel Pensado
    09/10/2019 15:50
    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.
  • Manoj Swaminathan
    10/10/2019 05:43
    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).
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