The signal is not the whole story
AI may help classify cases or surface safety signals, but a reviewer also needs to see the data considered, the algorithm and version used, and the reason a signal was raised or dismissed.
Integrity is already an operating expectation
Good pharmacovigilance practice and electronic-record controls place weight on attributable, time-stamped audit trails. A summary dashboard cannot replace the history of a particular case and its human review.
Preserve the decision path
At the point of use, capture the output, applied checks, escalation and final human action. That record helps teams revisit a safety decision when new information arrives.
Basis
EU Good Pharmacovigilance Practices · 21 CFR Part 11 §11.10(e) · EU GMP Annex 11 · Draft Annex 22