The medicine arrived. The question is whether your evidence holds.
ambiwize turns every pharmaceutical shipment into an audit-ready evidence record, built continuously from origin to destination, so governance travels with the cargo.
Append-only record. Every event is written once, with an accountable party, a timestamp and documented.
01 — The challenge
Every link sees its own leg. Nobody sees the whole lane.
Most operators have strong visibility over their own transport. The gap opens the moment the box crosses into a third party's hands — an air cargo agent, a last-mile carrier, a cross-dock. And the visibility they do have tracks the truck or the container, not the individual box inside it.
Pharmaceutical regulations worldwide — from ANVISA RDC 430/653 in Brazil to EU GDP and WHO GDP guidelines globally — require that the storage conditions defined by the manufacturer be maintained and demonstrated throughout the entire distribution chain, including every third-party leg. Compliance evidence cannot be built afterward. What is missing is not data: it is the chain that ties each reading, at box level, to a responsible party, a moment and a document.
$ per month provisioned in debit notes for loss and SLA breach at one large healthcare logistics operator
of that tied to temperature excursion or SLA breach; the other 20% is physical damage
$ in fines for a most serious sanitary infraction, doubled on repeat offense
02 — Field notes
The problems nobody budgets for, until the day they cost a fortune.
Situations described by logistics operators, carriers and pharmaceutical manufacturers in field conversations.
The investigation that cost more than the medicine.
A deviation opens a CAPA. Quality reconstructs the journey out of emails, spreadsheets and the memory of whoever was on shift. Weeks later, the accumulated cost of the investigation exceeds the value of the cargo it was meant to protect.
See the module →The meeting where every party brings its own data.
The penalty has been raised and nobody agrees where the failure happened. Shipper, operator and carrier each bring the record of their own leg. Without a common record the conversation repeats every month and ends in cost-sharing rather than root cause.
See the module →The ice change scheduled by estimate, not by information.
Quality calculates transit time and box type, then instructs the driver to change the ice at a given point. If the trip runs late, if the box warms early, or if the stop does not happen as planned, nobody finds out in time. The decision was made yesterday, on yesterday's information.
See the module →The transfer-point excursion nobody could attribute.
Temperature rose during a dwell between pickup and the transfer line. The shipper points at the operator, the operator points at the carrier, and no record says who held custody in that interval. The argument runs for weeks and ends with nobody accountable.
See the module →The claim that takes six months and settles low.
The cargo arrived compromised and the claim was filed. The insurer asks for proof that conditions were maintained up to the point of failure, and the operation produces partial readings and a hand-assembled report. The process drags and the recovery lands well below the value of the product.
See the module →The audit where the data existed but the chain of custody did not.
The inspector does not question the temperature reading. He questions who was accountable at each handover, whether the signatures exist, and whether the record could have been altered afterward. A temperature chart answers none of those three questions.
See the module →
03 — The platform
Five pillars of evidence. One continuous record.
Every shipment runs across all five. No system replacement, no parallel control tower. The platform runs standalone or fully integrated with your TMS and ERP.
04 — How it fits
It does not replace your systems. It augments them.
Your TMS, ERP and dataloggers each capture their own corner of the operation. ambiwize augments them with the custody events, box-level condition records and document validation they cannot produce alone — delivering a unified compliance view across the full journey.
Talk to the team
Ready to see the evidence in action?
Tell us about your operation and what your audit requires. We respond directly, no generic pitch.