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.
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.