Use-Case Blueprint · Free PDF
A governed agentic pipeline for adverse-event intake, the safety call kept human.
Every incoming report is a small dossier that must be made valid, complete, coded and de-duplicated against a fixed clock. The seriousness, causality and expedited-reporting decisions stay with a qualified person.
What's inside
- The six agents mapped to intake: the four minimum criteria, MedDRA coding, and deduplication before the database corrodes.
- The decision boundary at REQUIRE-HUMAN, and the taint boundary that keeps an untrusted report from hijacking an agent near the safety database.
- A compliance map to EMA GVP, ICH E2B, EU GMP Annex 11, ALCOA+, GDPR and the EU AI Act, each tied to a named control.
- A Foundation on one intake stream in six to eight weeks, measured on cost per case, latency, quality lift and concordance.
Use-case blueprint · PDF · Pharmacovigilance
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