Platform
Serialization
Serialization is where labeling meets the physical line. The requirement is straightforward to state and unforgiving in practice: unique numbers, applied correctly, recorded as they are applied, at the rate the line actually runs. RONOVA serializes the label and keeps the record of it.
What it does
Serial numbers without collision.
Numbers are generated or drawn from an allocated range so the same identifier is never issued twice, including across sites and contract manufacturers.
Aggregation as packing happens.
Unit-to-case and case-to-pallet relationships are captured at the point of packing, which is the only point at which they are known.
Verification at the line.
Applied codes are checked for readability, so an unreadable carrier is caught in production rather than at a customer's receiving dock.
A record you can stand behind.
Every identifier issued is recorded against the template revision it was printed from, the site and line that printed it, the time, and the person accountable, in the same audit trail as every other labeling action.
Handed to the system that reports.
Serial data is made available to the repository or trading-partner system that performs track and trace. RONOVA produces and proves the identifiers those systems depend on rather than operating the network itself.
How it works
Allocate ranges to sites.
Each site or line receives its own allocation, so numbers stay unique without every line depending on a live central call at print time.
Print and verify in one pass.
The carrier is applied and read back. A failed read is handled as a controlled exception rather than by discarding the number silently.
Build the hierarchy at packing.
As units go into cases and cases onto pallets, the parent-child relationship is recorded, producing the hierarchy traceability depends on.
Reconcile the batch
Numbers issued, applied, rejected and shipped are reconciled at batch close, so discrepancies are found while the batch is still in hand.
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 Falsified Medicines Directive 2011/62/EU
- US Drug Supply Chain Security Act (DSCSA)
- GS1 standards: GTIN, SSCC, GS1 DataMatrix
- 21 CFR Part 11: records of applied identifiers
Questions about this capability.
How is serial number uniqueness maintained across multiple sites?
By allocating distinct ranges to each site or line rather than issuing every number from a single live service. Sites cannot collide because their ranges do not overlap, and a network interruption does not stop a line.
What happens when a code fails verification?
It is handled as a controlled exception: the number is recorded as rejected rather than silently reused or discarded. Batch reconciliation then accounts for every number issued, which is what makes the shipped set defensible.
Related capabilities
Traceability
Full genealogy from incoming material to shipped unit, queryable for the product's regulatory retention period.
Label Management
Design, approve and print labels from one controlled source, with electronic approval and a complete audit trail on every change.
Regulatory Data
One master record for product and regulatory attributes, so the label, the artwork and the ERP cannot disagree with each other.
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