Operator surface for adverse-event queue management, signal detection clusters, regulator-reporting deadlines (FDA MedWatch 15-day / EU MDR vigilance / PMDA), and causality-assessment workflow.
Single-page operator surface served as static HTML — no backend, no login, no telemetry. Synthetic data only. Part of the Kinetic Gain operator-surface lane.
This is HealthTech / Pharma PV (Pharmacovigilance) — a buyer-facing operator dashboard that demonstrates the shape of a runtime governance system for pharmacovigilance review and reporting hub without exposing any live tenant data. Synthetic data lets prospects and reviewers explore the workflow end-to-end before they ever connect a real source.
Pharma PV teams · Drug safety officers · Medical-device adverse-event committees · Sponsor QA
FDA 21 CFR 314.80 (MedWatch) · 21 CFR 803 (medical-device MDR) · EU Regulation 2017/745 (EU MDR) · ICH E2A-E2F · PMDA Article 68-10 · GVP Modules I-XVI
The page is pre-loaded with synthetic data modeled on Helios Therapeutics (mid-cap pharma, 4 marketed products, ~120-event monthly PV intake) — a realistic operator scenario so the workflow looks like production from first paint. Browser-only; nothing leaves the tab.
v1.0-prod — hardened 2026-06-02. CI green on Node 20+22, 15 structure + data-integrity tests passing, HTML5-validated, security headers verified in .htaccess. See .release-notes.md.
- No backend. No database. No login. No telemetry.
- Synthetic data is baked into the HTML as JavaScript constants.
- All filtering, sorting, audit-chain rendering happens client-side.
- Hostinger native git pull deploy via FTP-Deploy-Action.
Per the Kinetic Gain public-language guardrail across HIPAA · FERPA · SOC 2 · GDPR · ISO 27001 · NIST AI RMF · EU AI Act · ISO 42001: this surface frames as readiness / evidence / posture / controls / scaffolding — never "compliant" or "certified" unless an external audit is currently attested and in scope.
AGPL-3.0. The KG Suite specs that compose with this surface (Decision Card v0.3 vault contract, AI Incident Card, AI Evidence Format, audit-stream) are MIT — see github.com/mizcausevic-dev/kinetic-gain-protocol-suite.
- Kinetic Gain Protocol Suite hub — the 11 specs + 11 vertical 6-packs
- Apex /constellation/ — full grouped index of all kineticgain.com surfaces
- Portfolio dashboard — programmatic catalog of 555+ public repos
Miz Causevic · Boston · github.com/mizcausevic-dev · linkedin.com/in/mirzacausevic