Smarthub Connect™ L5 Solution

Level 5+ Pharma Traceability Infrastructure for National Regulatory Control

SMARTHUB CONNECT

Most systems move data.
We run the program.

Validated-at-ingest traceability submissions, shared Validation Receipts, and real-time oversight, so onboarding scales, exception loops shrink, and audits are defensible.
National L5 succeeds or fails on onboarding throughput, data quality, and exception resolution; we’re built to operationalize all three.
When ambiguity and exception loops scale, illicit and substandard products find the gaps; operational control closes them.
Built on GS1 EPCIS: Accept EPCIS 1.2/2.0 (XML/JSON/JSON-LD) → normalize to a canonical JSON-LD model for consistent validation and audit.
Validation Receipts confirm submission integrity and validation outcome. They do not constitute product approval or regulatory authorization.

The real L5 problem

What The Industry Lives With

L5 programs don’t break because EPCIS isn’t a standard.
They break because, at national scale, four forces overwhelm everyone:

Onboarding Throughput

Getting dozens or hundreds of MAHs connected and submitting usable data

Exception Economics

Structural issues, inconsistent completeness, and relentless remediation loops

Connectivity Friction

AS2/API setup, certificates, transmission issues, trading-partner configuration

Master Data Alignment

Mismatched expectations across identifiers, locations, and rule interpretations

SmartHub Connect is built to solve those realities, not just collect submissions.

What’s different:
We normalize every submission into one canonical model, enforce ministry-defined rules consistently, and issue shared Validation Receipts that power real-time oversight and exportable audit packs.

What Does a Real L5 Program Look Like?

A Real L5 Program Is An Operating Model. Not A Data Pipe.

Governed rules icon for MVC Level 5 pharmaceutical compliance program

Governed rules

The Ministry defines the validation policy. SmartHub Connect enforces it consistently across every MAH, so requirements are clear, outcomes are predictable, and enforcement is defensible.
Validated-at-Ingest icon for pharmaceutical supply chain data integrity

Validated-at-ingest execution

We normalize submissions into one canonical model (JSON-LD) and validate at ingest, so issues are caught early, remediation cycles shorten, and first-pass success improves as the program scales.
Shared Proof icon for pharmaceutical program oversight and compliance

Shared proof + program oversight

Every submission produces a Validation Receipt shared by MAH and regulator, and every outcome feeds real-time oversight, so the Ministry manages adoption, exceptions, and cycle time with evidence, not escalation.
Real L5 pharmaceutical traceability operating model diagram – program infrastructure not just a data pipeline
Onboarding becomes measurable, exceptions become manageable, and audits become straightforward, because every outcome produces a receipt, and every receipt exports.
Governed rules + shared receipts + operational oversight, so adoption becomes manageable and enforcement becomes defensible.
Validated-at-Ingest

The Foundation For Trust

Validated-at-ingest isn’t a slogan; it’s how national programs avoid downstream chaos. The user experience is built to turn failures into fast correction cycles:
Catch issues early, shorten remediation cycles, and improve data quality as volume grows.
Validated-at-Ingest foundation for pharmaceutical supply chain trust and regulatory compliance
Compliance You Can Prove

Validation Receipts

When programs scale, ambiguity becomes operational debt: What was submitted? When? What passed? What failed?
SmartHub Connect issues a Validation Receipt for every submission, tamper-evident, traceable, and exportable as an audit package. MAHs and regulators see the same receipt in the portal, backed by a validation report and supporting logs.
How SmartHub Connect validation receipts work – pharmaceutical compliance workflow diagram
Every Validation Receipt includes:
Capture ID • Timestamp • Dataset hash • Status
Validation Receipts confirm
Submission integrity + Validation outcome.
They are not regulatory approval.

For Ministries of Health / Regulators

a guided program journey

SmartHub Connect is designed around the regulator’s operational journey-from launch to scale-through a UX that makes adoption measurable, exceptions manageable, and audits defensible.

How the regulator experience delivers value

Governed Rules: See onboarding progress, submission quality, and systemic bottlenecks in real time.
Exception Resolution Workflow: Track failures by severity, age, and SLA; drive remediation cycles to closure.
Exportable Audit Packs: Export receipts, validation reports, and audit packs on demand.
Governed Policy Execution: Ministry-defined, versioned rules applied consistently across MAHs.
Ministry of Health Regulator Control Tower oversight dashboard for L5 pharmaceutical traceability

What the Regulator Sees From Day One

Run onboarding and exceptions like an operating program – not a ticket queue.

FOR MAHs

a clean onboarding journey with fewer rejects

SmartHub Connect is designed around the MAH experience, from onboarding to daily submissions, so teams spend less time firefighting and more time moving product.

How the MAH experience delivers value

Recommended production channels:
AS2 + REST API
(SFTP legacy; web upload for onboarding/tests)

What we validate at ingest (high level)

Mobile Verification

Trust at the point of scan

Scan a barcode and validate product details against authoritative program data. Designed for government inspectors and consumers, extending program trust into the field without complicating the L5 backbone

What users get

Proof/Reference

Reference Program

EFDA / Ethiopia: SmartHub Connect™ is supporting the initial onboarding and EPCIS validation cycles for the national pharmaceutical traceability program. As the program scales, MVC expects to publish measurable outcomes across onboarding throughput, validation pass rates, exception reduction, and audit readiness.
Ethiopian Food and Drug Authority (EFDA) logo – Medical Value Chain reference program partner

Turnkey deployment

Built for National Scale

We deploy SmartHub Connect as a program – not just software. Our approach covers regulator configuration, MAH onboarding waves, technical enablement, and operational support – so go-live doesn’t become go-manual.

Next Steps

30-minute Briefing

To Align On Objectives And Rollout Approach

01

Pilot Ingestion

With Select MAHs To Prove The Flow

02

Scale Plan

For Onboarding Waves, Oversight Cadence, And Go-live Execution

03

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