Smarthub Connect™ Solution L5

Infrastructure de traçabilité pharmaceutique de niveau 5+ pour le contrôle réglementaire national

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

La plupart des systèmes déplacent des données.
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
Soumettre

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

Le three pillars

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

Validé-à-l'ingestion

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.

Sécurité

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

Prochaines étapes

Bref exposé de 30 minutes

Briefing to align on objectives and rollout approach

01

Ingestion pilote

Pilot ingestion with a defined cohort

02

Plan d'échelle

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

03

fr_FRFR