Smarthub Connect™ L5 Lösung

Pharma-Rückverfolgbarkeitsinfrastruktur Level 5+ für nationale regulatorische Kontrolle

Security & Data Sovereignty

Sovereign control. Defensible evidence.

Audit-ready trust.

SmartHub Connect™ is built for national programs where integrity and governance are non-negotiable. We enforce ministry-governed validation at ingest, generate evidence-grade submission receipts, and provide operational oversight, so programs scale
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Security Discipline

Security designed for programs.
Not just systems

National traceability fails when security is treated as a checklist and exceptions become permanent. SmartHub Connect™ treats security as an operating discipline:

Validierte Ausführung

Rules are enforced consistently at ingest, before bad data spreads.

Evidence artifacts

Every submission produces a receipt and an audit trail that can be exported.

Operational oversight

Program performance is measurable (adoption, exceptions, remediation velocity), not anecdotal.

Trusted Governance

Sovereignty by design

  • Validation policy and change governance (versioned
    rules, traceable outcomes)
  • Roles and access aligned to authority
  • Program boundaries for visibility and data exposure
  • Control
  • Program configurations and policies
  • Evidence artifacts (receipts, logs, proof exports)
  • Exportable oversight metrics and audit packages
  • Tragbarkeit

Audit Integrity

Audit-ready integrity that stands up to disputes

  • Tamper-evident records: Protected against undetected modification.
  • Submission chain-of-custody: Who submitted what, when, which rules applied, and what outcomes resulted.
  • Deterministic replay (where required): Reproduce outcomes from the same input and ruleset to resolve disputes with facts.

Hyperledger Fabric Attestation
Compliance Proof Anchoring

Smarthub Connect™ uses Hyperledger Fabric to anchor a tamper-evident compliance proof for each completed capture. This is not ‘blockchain hype.’ It is an operational proof artifact tied to a specific submission and outcome.
  • Reads the authoritative manifest.json output and computes a deterministic DocumentRootHashV1
  • Writes an AttestationRecord v1 as an anchor transaction to Hyperledger Fabric and receives a TxID
  • Stores and displays the Root Digest and TxID alongside the submission outcome
  • Includes these values in an exportable Proof Package for audit and dispute workflows

How SmartHub ConnectTM DLT Compliance Proof works

Hyperledger Fabric attestation anchors a tamper-evident compliance proof for each completed capture.

MAH submits EPCIS data

AS2, REST API, or web upload

SHCx validates & hashes

Computes DocumentRootHashV1

Anchor to Hyperledger Fabric

Writes AttestationRecord v1

Tamper-evident receipt

Root digest + TxID on portal

Download proof for audit trail

Exportable Proof Package

Hover, click, or use Tab + Enter to step through the workflow

Step 1 : Submission received

Status

Received

Submission ID

SHC-2026-05-14-A7F3C9

Sender (MAH GLN)

5410799000023

Payload

84,213 EPCIS events

Received at

2026-05-14 14:32:08 UTC

This proof confirms processing integrity and validation outcome. It is not a regulatory approval decision.

Step 2 : Validated and hashed

Status

Validated ✓

Schema check

EPCIS 2.0 — passed

GS1 syntax

SGTIN, SSCC — passed

Business rules

0 errors, 0 warnings

DocumentRootHashV1

a7f3c9e2d1b4c8e6...b9d2e1f7

This proof confirms processing integrity and validation outcome. It is not a regulatory approval decision.

Step 3 : Anchored to Hyperledger Fabric

Status

Anchored ✓

Channel

nhra-mvc-bh

DocumentRootHashV1

a7f3c9e2d1b4c8e6...b9d2e1f7

Fabric TxID

8a3fc1d2e7b4f5a9...b2c1f7e9

Block height

2,847,103

This proof confirms processing integrity and validation outcome. It is not a regulatory approval decision.

Step 4 : Tamper-evident receipt issued

Status

Compliant ✓

Fabric TxID

8a3fc1d2e7b4f5a9...b2c1f7e9

Endorsed by

NHRA-MVC MSP, MAH MSP

Issued at

2026-05-14 14:33:41 UTC

Action

View receipt on portal

This proof confirms processing integrity and validation outcome. It is not a regulatory approval decision.

Step 5 : Proof package ready

Status

Available for download

Package contents

Manifest, payload, hash, TxID, signed receipt

Format

ASiC-E signed bundle (CAdES-LT)

Retention

10 years

Action

↓ Download Proof Package

This proof confirms processing integrity and validation outcome. It is not a regulatory approval decision.

Access Control

Permissioned access with accountability

  • Role-based access control aligned to program governance
  • Credentialed participation for submitting parties
  • Accountability trails for exceptions and remediation actions
Secure pharmaceutical data protection icon - AVC SmartHub Connect trusted EPCIS submission and compliance security

Privacy

Privacy and controlled disclosure

Public or field verification should reveal only what is necessary to confirm authenticity and safety. SmartHub Connect™ supports controlled disclosure so sensitive supply chain data is protected while trust can extend into the field.

What ministries can export
Evidence not screenshots

  • Submission receipts and validation reports
  • Exception and remediation history
  • Audit packs and proof packages (where enabled)
  • Oversight metrics (adoption, pass/fail, cycle time, root causes)
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