Every dose accounted for. Every degree logged.
For pharma manufacturers, CDMOs, CROs and distributors. We design temperature, location and chain-of-custody programmes for clinical-trial materials, biologics and high-value drugs — built to satisfy 21 CFR Part 11, EU GDP, DSCSA and EU FMD auditors.
Hardware-agnostic across RFID, BLE and cellular sensor loggers.
Pharma & life sciences: the use case, and the numbers it moves.
The right radio for each job — chosen, never sold — mapped to your use case. That is what makes the ROI fast.
1 · Serialise
Items are serialised to DSCSA and 21 CFR Part 11.
2 · Monitor
Cold-chain sensors track temperature and custody continuously.
3 · Respond
Excursions trigger alerts and an audit-ready chain of custody.
Passive RFID → serialise · sensors → cold-chain · BLE → custody
What we keep seeing.
Cold-chain excursions go unseen
A freezer drifts overnight and no one knows until the morning round. By then a batch of biologics may already be out of spec — a six-figure write-off and a deviation report.
Chain-of-custody is paper
Clinical-trial kits move between depot, courier, site and patient on signature sheets. Reconstructing who held what, and when, for an audit is slow and error-prone.
Serialisation is bolted on
DSCSA and EU FMD serialisation often sits in a silo from the rest of the supply chain, so aggregation and verification break at the pack and pallet level.
The use cases that consistently pay back.
Cold-chain monitoring
Continuous temperature, humidity and shock logging with real-time alerting before product goes out of spec.
Clinical-trial chain-of-custody
Sealed, audit-grade custody from depot to site to patient, with 21 CFR Part 11 electronic records.
Serialisation & aggregation
Item, pack and pallet serialisation aligned to DSCSA and EU FMD, with EPCIS event sharing.
High-value asset tracking
Locate and secure controlled and high-value drugs across the distribution network.
Excursion management
Automated quarantine and deviation workflows the moment a threshold is breached.
Last-mile & courier visibility
Cellular and GPS tracking of shipments in transit, with ETA and condition.
Hardware & software ecosystem
RFID temperature loggers · BLE condition sensors · cellular cold-chain trackers · 21 CFR Part 11-validated platforms — selected for your regulatory and environmental requirements, never by price book.
Where we plug in
SAP · Oracle · LIMS · MES · serialisation / Level-4 systems · EPCIS repositories · QMS and deviation-management platforms.
What good looks like.
What we design and document to
21 CFR Part 11 · EU GDP (2013/C 343/01) · DSCSA · EU FMD (Delegated Regulation 2016/161) · GS1 EPCIS · GAMP 5 · ISO 17025-aligned calibration.
Where the payback shows up.
Clinical-trial kit tracking
Sealed chain-of-custody for trial materials from depot to site, audit-trailed for the sponsor and the regulator.
Biologics cold-chain
Continuous temperature and shock logging with automatic quarantine on excursion, protecting high-value batches.
Serialised distribution
Item-to-pallet aggregation and verification across DSCSA and EU FMD, with EPCIS sharing to partners.
For clinical-trial logistics, a single temperature excursion can scrap a batch. Continuous location, temperature and shock monitoring with a 21 CFR Part 11 audit trail cut our excursion response time dramatically and took roughly 90% off audit-prep effort. It worked because TRACIO designed it compliance-grade from the outset.Director, Clinical Supply Chain · top-5 global pharma · globalAnonymised at the client’s request. Reference available on request.
Relevant case studies
Common use cases — what we keep seeing.
DSCSA (US) serialisation and aggregation compliance
Problem: Every prescription unit in the US must carry a serialised identifier with full chain-of-custody — non-compliant shipments are blocked at the wholesaler.
Tech mix: GS1 SGTIN on every unit (barcode + Passive RFID), aggregation to cases and pallets, EPCIS repository integration.
Outcome: DSCSA-compliance evidence per unit, suspect-product investigations close in hours not days, returns processing automated.
EU FMD verification at point of dispense
Problem: EU Falsified Medicines Directive requires verification of every prescription pack at the pharmacy — non-verified packs are blocked.
Tech mix: GS1 DataMatrix barcode + tamper-evidence, NMVS-interface at the pharmacy, integration with pharmacy systems.
Outcome: FMD compliance with sub-second verification, falsified-pack detection at dispense, regulator-audit-ready logs.
Cold-chain compliance for vaccines and biologics
Problem: Vaccines and biologics have strict cold-chain requirements (2-8°C, sometimes <-70°C) — excursions cause batch loss.
Tech mix: BLE or LoRaWAN temperature loggers, gateway coverage in fridges/freezers, integration with vaccine management software.
Outcome: Excursion-driven batch loss reduced 60%+, regulator-audit evidence per dose, mAb and cell-therapy supply integrity.
Clinical trial sample chain-of-custody
Problem: Clinical trial samples must be tracked from collection through analysis with full chain-of-custody for FDA/EMA submission.
Tech mix: Passive RFID on every sample, fixed readers at collection, transport, lab, integration with LIMS.
Outcome: Sample-loss eliminated, CoC evidence per sample, submission package preparation faster.
Reverse-logistics and returns for controlled substances
Problem: Schedule II-V controlled substances returned for destruction must be tracked at unit level under DEA regulations.
Tech mix: Passive RFID on every return, secure transport with GNSS chain-of-custody, integration with DEA reporting tools.
Outcome: DEA-21 compliance verified, returns processing time reduced, audit-ready evidence per unit.
Pharmacy automation and dispensing-cabinet integration
Problem: Hospital pharmacies use automated dispensing cabinets (Pyxis, Omnicell); RTLS context (nurse identity, patient location) reduces medication errors.
Tech mix: BLE-AoA on nurse badges, dispensing-cabinet integration, EMR linkage for patient-bed location.
Outcome: Medication-error rate reduced 30%+, dispense-to-administer time down, BCMA compliance improved.
Bulk-API and excipient tracking in manufacturing
Problem: Active pharmaceutical ingredient (API) batches feed multiple finished-drug runs — batch-genealogy traceability is critical for recalls.
Tech mix: Passive RFID on every API container, batch-MES integration, full lot-genealogy capture.
Outcome: Recall response time reduced from days to hours, GMP-compliance evidence improved, raw-material write-offs down.
Operator-aseptic-zone access control
Problem: Aseptic-manufacturing zones (Class A/B grade) restrict personnel access by training and gowning status — mistakes risk batch contamination.
Tech mix: BLE-AoA on operator badges, gowning-station integration, aseptic-zone access interlock.
Outcome: Contamination events from access errors eliminated, Annex 1 / GMP audit-readiness, training compliance verified.
Equipment-cleaning verification (clean-in-place)
Problem: Pharma manufacturing equipment cleaning must be validated and traceable — disputed cleaning is a major audit finding.
Tech mix: Passive RFID on equipment, cleaning-station fixed readers, integration with cleaning-validation database.
Outcome: Cleaning compliance verified per equipment-batch, GMP audit findings reduced, EBR/BMR records complete.
Hospital consignment stock tracking
Problem: High-value hospital consignment (oncology, biologics) is rotation-sensitive and expiry-driven; manual management causes write-offs and OR-readiness gaps.
Tech mix: Passive RFID on every unit, hospital-pharmacy smart cabinets, integration with hospital materials management.
Outcome: Write-offs reduced 30-50%, OR-readiness on consignment 99%, manufacturer recall traceability per unit.
Frequently asked questions
What does RTLS/RFID give pharma operations?
Serialised accountability of every dose, cold-chain condition logging, and equipment and asset tracking - so both compliance and efficiency improve on one platform.
Does it support DSCSA, GS1 and 21 CFR Part 11?
Yes - serialisation, chain of custody and condition records align with DSCSA, GS1 and 21 CFR Part 11-aligned data-integrity requirements.
How is cold-chain monitored end to end?
Wireless sensors log temperature, and humidity and excursions, across storage, transport and handling, with real-time alerts before product is compromised.
Can it track lab and production assets?
Yes - the same platform locates mobile equipment and instruments, cutting search time and supporting calibration and maintenance.
How does it integrate with our systems?
Serial, custody and condition data feed your ERP, QMS and LIMS via API, keeping records centralised and auditable.