Pharmaceuticals
Patient safety starts with supply chain integrity
Pharmaceutical manufacturers and distributors use Trailio to meet serialisation mandates, prevent counterfeit medicines, and maintain cold-chain compliance records.
- 100%
- DSCSA/EU FMD compliance readiness
- 1 in 10
- Medicines globally are counterfeit
- 45%
- Cold chain savings through IoT monitoring
Operational challenges
Industry-specific problems Trailio is built to address.
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Regulatory serialisation mandates (DSCSA, EU FMD)
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Cold chain integrity and temperature excursions
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Counterfeit drugs entering supply chains
Trailio platforms for Pharmaceuticals
Unit-level serialisation and verification.
Explore platformTemperature-logging smart tags for cold chain.
Explore platformAutomated pharmaceutical excise compliance.
Explore platformPharmaceuticals operational overview
How Trailio's intelligence platforms operate in pharmaceuticals environments.
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Pharmaceutical cold chain excursion detection and documentation
A batch of 10,000 serialised pharmaceutical units is despatched from Frankfurt to Hamburg with cold chain monitoring active. A temperature excursion triggers an automated QA alert mid-route. The batch is quarantined and reviewed before being released and delivered to the pharmacy - with a complete temperature and custody record available for regulatory review.
Illustrative operational scenario - demonstration data only
Event Sequence
- Batch serialisation at manufacture - DSCSA identifiers issued 06:00Manufacturing QA
Batch: PH-MFG-00841 · Units: 10,000 · DSCSA SGTIN applied to each unit - QC scan - serialisation verification complete 06:30QA Station 3
Verified: 10,000 / 10,000 · EPCIS event recorded · Batch released - Despatch to 3PL cold chain - custody transfer recorded 08:00Frankfurt Distribution
Carrier: PharmaLogistics EU · Seal #HSA-PH-0041 applied and registered - Temperature excursion detected - IoT alert triggered 10:30In Transit, Munich
AssetTag TMP-041: +3.2°C above threshold for 12 mins · Batch quarantined - QA review initiated - batch hold instruction issued 10:45QA System
Pharmacist QA-EU-007 alerted · Hold instruction: PH-HOLD-00841-01 - Temperature review completed - batch released after assessment 14:00QA Decision Record
Excursion assessed as within acceptable range · Release authorised by QA-007 - Pharmacy receipt - DSCSA verification confirmed 16:30Hamburg Central Pharmacy
Pharmacist scan: all 10,000 units verified · Dispense records activated
Temperature excursion detected at 10:30 and documented with IoT record. QA review completed and batch released by authorised pharmacist. All 10,000 units verified on pharmacy receipt. Full cold chain and custody audit trail on record.
Operational stack
Pharmaceutical operational stack
How Trailio modules and HSA physical security products integrate across a pharmaceutical manufacturer, 3PL, and distribution operation - from serialisation through pharmacy dispense.
Unit-level serialisation and verification - each medicine unit carries a unique DSCSA/EU FMD compliant identifier, verified at every custody transfer through the supply chain.
Temperature-logging smart tags for cold chain integrity - IoT-enabled monitoring of temperature excursions with automated alerts and immutable records for regulatory review.
Pharmaceutical excise and import duty compliance - automated calculations, documentation, and reporting for controlled substances and dutiable medicine categories.
Controlled substance chain of custody - every transfer of high-value or controlled pharmaceutical products recorded, verified, and auditable for regulatory inspection.
Tamper-evident containment for controlled substances and high-value medications in transit - serialised and linked to Trailio custody records.
Tamper-evident pharmaceutical labels - unit and carton level, compatible with DSCSA and EU FMD packaging requirements, registered in the Trailio identity layer.
Expected operational outcome
Pharmaceutical operators achieve DSCSA and EU FMD compliance readiness, automated cold chain monitoring, counterfeit detection at every supply chain tier, and a defensible audit trail for controlled substance traceability - reducing regulatory risk and improving patient safety outcomes.
Pharmaceutical operational outcomes
Measurable improvements reported by enterprise deployments in this sector.
DSCSA and EU FMD serialisation compliance
TrueBrand generates and manages DSCSA-compliant SGTIN identifiers and EU FMD serialisation records - providing unit-level traceability from manufacturer to dispense.
Cold chain excursion detection and documentation
AssetTag temperature logging creates an immutable record of cold chain conditions for every batch - with automated excursion alerts and QA decision records supporting regulatory review.
Counterfeit medicine detection at distributor and pharmacy level
Pharmacy and distributor scan events verify each unit against the original DSCSA or EU FMD record - flagging any product whose identifier does not match a genuine manufacture record.
Controlled substance chain-of-custody accountability
Every transfer of controlled or high-schedule pharmaceuticals requires a verified scan - creating a defensible, auditable custody record available for regulatory inspection without manual reconstruction.
Faster regulatory audit response
Batch traceability records, custody events, and exception documentation are query-accessible in real time - reducing audit preparation time from days to hours.
Parallel import and grey market detection
Products appearing in markets or pharmacies outside their registered distribution pathway trigger automatic alerts - protecting pharmaceutical pricing structures and regulatory compliance in each territory.
Industry Questions
Pharmaceuticals industry questions
Common questions from pharmaceutical manufacturers, distributors, and regulatory affairs teams evaluating Trailio for serialisation and traceability compliance.
Is TrueBrand compliant with DSCSA Track & Trace requirements in the US?
TrueBrand supports DSCSA-compliant serialisation - generating GS1-standard SGTIN identifiers and maintaining EPCIS event records for each product transfer. The platform supports the key DSCSA data elements: product identifier, serial number, lot number, and expiry date. EPCIS event data is API-exportable for trading partner sharing and regulatory submission.
Does the platform support EU FMD (Falsified Medicines Directive) compliance?
Yes. Trailio supports EU FMD unit-level serialisation, authentication at point of dispense, and decommissioning workflows. Integration with the European Medicines Verification System (EMVS) and national MAH systems is supported. Pharmacist verification scans are captured and recorded against the product identity in the Trailio platform.
How does AssetTag handle cold chain temperature monitoring for pharmaceutical shipments?
AssetTag supports IoT-enabled temperature data loggers that record conditions continuously during transit. Temperature thresholds are configurable per product category. Excursion events trigger automated alerts to QA teams, with the full temperature log available for pharmacovigilance review and regulatory documentation. Historical temperature records are retained with full batch traceability.
Can Trailio support audit trail requirements for controlled substances?
AssetShield creates a custody record at every transfer point - each handoff attributed to a named custodian with timestamp and location. For controlled substances, multi-party verification (dual-custody acceptance) is configurable. The resulting audit trail meets the documentation standard expected by DEA, MHRA, EMA, and equivalent agencies for controlled medicine traceability.
Can the platform detect counterfeit medicines entering the supply chain?
Yes. At each custody transfer and verification point, the product's serial identifier is verified against the Trailio identity record. Identifiers that do not match a genuine manufacture record, have been used more than once, or appear outside the expected distribution pathway trigger an immediate alert - preventing suspect products from continuing through the supply chain.
Does HSA supply security packaging specifically designed for pharmaceutical applications?
HSA manufactures tamper-evident security bags for controlled substance transit, pharmaceutical security labels compatible with GS1 serialisation requirements, and evidence bags for incident documentation. All HSA pharmaceutical packaging products can be serialised and integrated with Trailio for digital chain-of-custody tracking.
Have a sector-specific requirement?
Our industry specialists work with enterprise and government teams to scope deployments around specific operational and compliance requirements.
Discuss your Pharmaceuticals operational requirements
Our industry specialists work with enterprise and government teams to design Trailio deployments around your specific operational environment and compliance requirements.