Drug-safety agents

Pharmacovigilance governed Process blueprints

Runtime governance blueprints for pharmacovigilance agents (adverse-event intake and case processing) mapped to EMA GVP, ICH E2B/E2D, and FDA 21 CFR Part 11.

adverse-event case processing

Governing a Pharmacovigilance Adverse-Event Intake & Case-Processing Agent

You govern a pharmacovigilance case-processing agent by intercepting its high-stakes decisions before they commit — case validity, seriousness/expectedness, MedDRA coding, the Day-0 clock, and any ICSR submission or auto-close — with a policy gate that returns allow, warn, require_approval, or block, routes reportability and auto-close calls to a named qualified person via a maker-checker Escalation, and seals a cryptographically verifiable Lineage Record that doubles as the 21 CFR Part 11 audit trail. KLA does not build your PV agent; it governs the agent you built and produces the GVP/ICH/Part 11 evidence on every run.

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