UPT Process
Run Unreleased Product Tracking for every lab or clinical evaluation: chain of custody, accountability, and audit trail your QA team can defend.
Overview
Pre-release products at evaluation sites are a regulatory exposure. They are not yet under formal device controls but they are in the hands of clinicians making real decisions. Without disciplined tracking, the same engineering build can land at two sites, with two different configurations, and no single record reconciles them.
We run UPT as a formal process: every pre-release unit is logged, tracked through every site, and reconciled before the next stage of release. Lost units are caught early; configuration drift is documented.
Our Process
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1
Unit registration
Every pre-release unit assigned a UPT identifier separate from final UDI.
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2
Site dispatch tracking
Recipient, configuration, date received, condition on arrival.
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3
Configuration log
Any modification at a site triggers a configuration log entry.
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4
Return reconciliation
On evaluation completion, condition, configuration, and any field changes captured.
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5
Quality handoff
Findings that meet thresholds open a QMS record.
Frequently Asked Questions
Do we still need UDI tracking?
Yes, post-release. UPT is the pre-release equivalent that bridges into your formal UDI system.
What if units never come back?
Documented in the reconciliation report with the customer's accountability statement.
Can this work for software-only products?
Yes, UPT covers configuration and version tracking for software evaluations.
How granular are configuration logs?
To the level your QMS requires: typically firmware version, model parameters, calibration settings.
Track every pre-release unit until it is reconciled.
Tell us your current evaluation footprint. We will return a UPT operating plan within two weeks.
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