Serialization Compliance for Regulated Medical Device Production
A medical device manufacturer must maintain unit-level serialization and device history records across three production lines to satisfy regulatory requirements.
Run on Anvaya · Traceability & Product Data
The challenge
Device history records are assembled from line paperwork and ERP transactions after the fact.
Missing or inconsistent records surface during inspection, when correction is no longer possible.
Reconstructing the history of a single unit takes hours of manual searching across systems.
How Anvaya solves it
Serial Capture at Source
Each unit's serial is captured at the point of build rather than reconciled afterwards.
Automatic History Assembly
Process steps, operators, equipment, and material lots are attached to the serial as production happens.
Completeness Checking
Records missing a required element are flagged on the line, while the unit is still in the plant.
Instant Retrieval
Any unit's full device history is retrievable as a single record rather than reconstructed.
Inspection Readiness
Records are held in an inspection-ready state continuously rather than prepared for an audit.
The outcome
Device history assembled during production instead of reconstructed afterwards.
Incomplete records caught on the line rather than at inspection.
Unit history retrievable as one record rather than searched across systems.
Representative scenario: a modelled industry situation showing how this accelerator applies. Figures are projections, not a named client result.
Capabilities used
Every accelerator is assembled from the same capability layer, so a workflow you adopt here shares its foundation with the rest of the portfolio.
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