Pharma

Verifiable trust infrastructure for pharmaceutical operations

Pharmaceutical companies operate under the most demanding data integrity requirements in any regulated industry. GxP compliance, supply chain verification, and clinical trial data authenticity all require verifiable trust that extends across organisational boundaries.

Discuss pharmaceutical trust infrastructure

Pharmaceutical operations face three converging integrity mandates: GxP data integrity requirements under ALCOA+ principles, supply chain verification under the EU Falsified Medicines Directive, and clinical trial data authenticity under EU Regulation 536/2014. Each demands cryptographic proof of data provenance across organisational boundaries. The architectural approach proven in Swiss healthcare applies directly to pharmaceutical data exchange, batch verification, and regulatory submission integrity.

Regulatory drivers

GxP Data Integrity (ALCOA+)

Attributable, Legible, Contemporaneous, Original, and Accurate data integrity requirements governing all pharmaceutical manufacturing, distribution, and clinical operations.

100% of pharma operations subject to GxP

EU Falsified Medicines Directive

Mandatory serialisation and verification system requiring end-to-end supply chain authentication from manufacturer to dispensing point across EU member states.

27 EU member states with mandatory verification

Clinical Trials Regulation (EU 536/2014)

Harmonised clinical trial framework requiring verifiable data authenticity, audit trails, and cross-border trial data exchange between sponsors, sites, and regulators.

4,000+ clinical trials registered annually in EU

Solution overview

Verifiable trust infrastructure for pharmaceutical operations means every data exchange -- batch records, supply chain events, clinical trial submissions -- carries cryptographic proof of origin, integrity, and chain of custody. This is not a compliance overlay. It is an architectural capability that makes data provenance verifiable by design across manufacturing sites, distribution partners, regulatory authorities, and clinical trial networks.

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Proven at scale

Healthcare proved the architecture at scale. HIN -- operator of Switzerland's health information network -- processes over 800,000 verified messages per month through 850+ gateways serving 30,000+ healthcare institutions. The same infrastructure that verifies healthcare communications applies to pharmaceutical data exchange: organisational boundary trust, data provenance verification, and compliance attestation operate identically whether the payload is a patient record or a batch release certificate.

HIN — Health Info Net

800,000+

verified messages per month

850+

gateways across Swiss healthcare

30,000+

GP offices and healthcare institutions

See the full HIN case study

The ALCOA+ principles that govern pharmaceutical data integrity -- attributable, legible, contemporaneous, original, accurate -- map directly to the cryptographic properties of verifiable trust infrastructure: every data point carries proof of who created it, when, and whether it has been altered.

Reference architecture

GxP Data Integrity Layer Pharma Operations Manufacturing Site MES / ERP / LIMS Clinical Trial Network CTMS / EDC / eTMF Distribution Partner WMS / Serialisation Verified Trust Infrastructure Gateway Mesh 850+ gateways Verify Provenance Compliance Data provenance verification Chain of custody tracking ALCOA+ attestation 800,000+ verified messages / month DKMS / Decentralised Key Management Receiving Parties Regulatory Authority EMA / FDA / Swissmedic Supply Chain Partner EMVS / FMD Hub Clinical Data Repository CTIS / EudraCT Vereign AG -- Pharma Trust Infrastructure Reference Architecture

Click to expand diagram

GxP Data Integrity Layer Pharma Operations Manufacturing Site MES / ERP / LIMS Clinical Trial Network CTMS / EDC / eTMF Distribution Partner WMS / Serialisation Verified Trust Infrastructure Gateway Mesh 850+ gateways Verify Provenance Compliance Data provenance verification Chain of custody tracking ALCOA+ attestation 800,000+ verified messages / month DKMS / Decentralised Key Management Receiving Parties Regulatory Authority EMA / FDA / Swissmedic Supply Chain Partner EMVS / FMD Hub Clinical Data Repository CTIS / EudraCT Vereign AG -- Pharma Trust Infrastructure Reference Architecture

How to engage

Work with Vereign directly

For organisations that want to scope and deploy trust infrastructure with Vereign's engineering and advisory team. Ideal for first movers and organisations with in-house technical capacity.

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Work through a partner

For organisations that prefer to work with a consultancy already trained on Vereign's trust infrastructure. Partners provide sector expertise alongside deployment capability.

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Team voices

We designed this architecture for pharmaceutical operations because GxP data integrity and supply chain verification share the same fundamental requirement: every data exchange must carry cryptographic proof that it is authentic, unaltered, and attributable to its source.

Dr. Felix Greve Dr. Felix Greve COO, Vereign AG

Scope a trust infrastructure deployment for pharmaceutical operations

Whether you are addressing GxP data integrity, supply chain verification, or clinical trial data authenticity, we can help you define the right trust architecture.

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