Smarthub Connect™ L5 Lösung

Pharma-Rückverfolgbarkeitsinfrastruktur Level 5+ für nationale regulatorische Kontrolle

SmartHub Connect Platform Overview

A regulator-grade L5 platform

Built to run the national program.

SmartHub Connect™ validates traceability submissions at ingest, produces evidence-grade receipts (with optional compliance proof anchoring), and powers control-tower oversight, so onboarding scales, exception loops shrink, and audits are defensible.

What SmartHub Connect™ is

Die meisten Systeme bewegen Daten.
SmartHub Connect™ runs the program.

It turns national policy into measurable execution: ministry-governed rules, validated submissions, shared evidence artifacts, and KPI-driven oversight, so compliance becomes enforceable and outcomes become defensible.
SmartHub Connect runs the pharmaceutical program – beyond moving supply chain data

How SmartHub Connect™ works (end-to-end)

SmartHub Connect™ runs a consistent execution loop for every submission

Step:1
Einreichen

EPCIS via AS2/API; transitional options where required

Step:2
Normalize

Convert to a canonical model for consistent processing

Step:3
Validate at ingest

Ministry-governed rules applied consistently

Step:4
Issue evidence-grade outputs

Receipt + audit artifacts; optional
proof anchoring

Step:5
Operate with oversight

Dashboards and KPIs for adoption and enforcement readiness

Evidence-First Compliance Proof

Evidence-first compliance proof diagram for SmartHub Connect pharmaceutical traceability platform
Processing integrity proof – not regulatory approval

What the platform produces
Evidence not screenshots

SmartHub Connect produces verifiable evidence not screenshots – pharmaceutical supply chain proof

Die three pillars

Validated-at-Ingest real-time pharmaceutical product verification animation

Validiert-bei-Aufnahme

Catch issues early, shorten remediation cycles, and prevent downstream exception chaos.
Marketing authorization holders (MAHs) pharmaceutical document submission via SmartHub Connect

Evidence-Grade Receipts

Shared proof that both MAHs and regulators can reference during audits, escalations, and enforcement workflows.
Control Tower oversight dashboard for real-time pharmaceutical supply chain monitoring

Control-Tower Oversight

Dashboards and KPIs that make onboarding throughput, pass/fail trends, exception aging, and remediation velocity measurable.

Standards

Standards and interoperability

Built on GS1 EPCIS. We accept EPCIS 1.2/2.0 (XML/JSON/JSON-LD) and normalize submissions into a canonical model for consistent validation and audit readiness.
SmartHub Connect pharmaceutical data standards and interoperability – GS1 EPCIS and global regulatory compliance

Integrations built for scale

Recommended production channels: AS2 + REST API
Supported transitional options: SFTP (legacy) and portal upload for onboarding/tests.

Sicherheit

Security, sovereignty, and compliance proof

National programs require sovereign control, controlled disclosure, and audit-defensible evidence. SmartHub Connect™ supports evidence-first security, including optional compliance proof anchoring via Hyperledger Fabric attestation, so integrity can be demonstrated, not asserted.

Ecosystem

Built for the full ecosystem

Nächste Schritte

30-minütiges Briefing

Briefing to align on objectives and rollout approach

01

Pilot Aufnahme

Pilot ingestion with a defined cohort

02

Maßstabsplan

Scale plan for onboarding waves, oversight cadence, and enforcement readiness

03

de_DEDE