Platform
Traceability
Traceability is judged on the worst day, not the average one. The question is never whether records exist: it is whether they can be traversed backwards, from a suspect input to every customer affected, fast enough to matter.
What it does
Genealogy in both directions.
Forward from a material lot to the units that contain it, and backward from a shipped unit to everything that went into it.
Links captured as they form.
Relationships are recorded at the moment of packing or assembly, not reconstructed afterwards from separate records.
Retention-period queryability
Records stay queryable for as long as the product's regulatory retention requires, which for some devices is measured in decades.
Recall scoping
The affected set can be identified and bounded, so a recall is scoped to the units actually implicated rather than to a whole product line.
How it works
Identify every level
Material lots, units, cases and pallets each carry an identifier, because a chain is only traceable at the levels that are actually identified.
Record relationships at formation.
Each link is written when it is created: unit into case, case onto pallet, pallet onto shipment.
Preserve the chain
Records are retained under the same controls as other regulated records, so the chain remains intact and attributable over its full life.
Query in reverse
Investigation starts from whatever is known (a lot, a complaint, a serial number) and resolves the affected set from there.
Regulatory context
What this speaks to.
The regulations and standards this capability is built against. Always check the current text of any regulation before relying on it.
- EU MDR Article 25: identification within the supply chain
- 21 CFR 820.65: traceability
- US DSCSA: transaction information and history
- GS1 standards for identification and data capture
Questions about this capability.
How far back does traceability need to reach?
To the product's regulatory retention period, which for implantable devices can run to decades after manufacture. This is why retention and queryability have to be a design decision rather than an operational hope.
Does traceability depend on serialization?
Unit-level traceability does, because it needs a unique identifier per unit. Lot-level traceability does not, and is sufficient for many device classes. The right level follows from the product and its regulatory requirements.
Related capabilities
Serialization
Unique serial numbers issued, applied and recorded under the same change control as the rest of the label, at production line speed.
Label Management
Design, approve and print labels from one controlled source, with electronic approval and a complete audit trail on every change.
Ditch the manual redlining.
Watch automated audit trails build themselves.