Smarthub Connect™ L5 Решение

Уровень 5+ Инфраструктура прослеживаемости фармацевтической продукции для национального регуляторного контроля

Brand Protection
& L5 Compliance for MAHs

СмартХаб Коннект is designed to make MAH compliance predictable. We standardize onboarding, validate at ingest, and issue a Validation Receipt for every submission, so your team spends less time firefighting exceptions and more time moving product.

Standards

first 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.
Pharmaceutical MAH managing EPCIS compliance submissions digitally – AVC SmartHub Connect validated-at-ingest solution

The MAH reality

Most MAHs don’t struggle because they ‘don’t have EPCIS.’ They struggle because onboarding is slow, requirements are unclear, and failures become endless remediation loops.
СмартХаб КоннектTM is built to change that operating reality: clear requirements, consistent validation, actionable feedback, and shared proof.

How
MAHs connect

API cloud integration icon for AVC SmartHub Connect pharmaceutical traceability data transmission
Рекомендуемые каналы производства:

AS2 + REST API

EPCIS data file transfer between pharmaceutical MAH and AVC SmartHub Connect traceability platform
Supported for transitional use:

SFTP (legacy)

EPCIS submission file upload to AVC SmartHub Connect pharmaceutical traceability system
Supported for onboarding/tests:

Web portal upload

We guide MAHs to the fastest viable path based on technical maturity, without turning onboarding into a blocker.
Submission Flow

What happens when you submit

Квитанции на подтверждение

Validation Receipts: proof you can use

Every submission generates a Validation Receipt that both MAH and regulator can reference. This ends ambiguity in audits, escalations, and disputes.
Each Validation Receipt includes:
Receipts can be exported with a complete audit pack (receipt + validation report + supporting logs).
Квитанции об обратной проверке подтверждают целостность подачи + результат проверки. Они не являются разрешением регулирующих органов.

high level
What we validate at ingest

Validation is designed to prevent downstream chaos and reduce resubmission loops:

Why outcomes become predictable

СмартХаб КоннектTM reduces variation by normalizing all supported formats into one canonical model and enforcing the regulator’s rules consistently.
Result: fewer surprises, fewer resubmissions, shorter time-to-validation, and a clearer operational workflow for MAH teams.

Onboarding

Onboarding: what to expect

Support

How we support you

AVC SmartHub Connect MAH onboarding support – team training, compliance verification, and pharmaceutical traceability program guidance

MAH
FAQs

1. Do you accept EPCIS 1.2 and 2.0?
Yes—EPCIS 1.2/2.0 in XML/JSON/JSON-LD.
You receive clear failure reasons, remediate, and resubmit. The goal is shorter correction cycles, not ticket chaos.
No. It confirms submission integrity and validation outcome, not regulatory approval.
SFTP is supported for legacy use and transitional flows. Recommended production channels are AS2 + REST API.

Следующие шаги

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