Biobank sample management with chain of custody intact
A specimen whose chain of custody cannot be reconstructed is a specimen whose results cannot be defended. In most biobanks that reconstruction still depends on a spreadsheet and someone's memory.
Axira sample management tracks specimens, their locations, their conditions, and every hand they have passed through. Consent status, freeze and thaw history, aliquot lineage, and study allocation are held as part of the record rather than in separate systems that have to be reconciled.
The point is not inventory. The point is that when a result is questioned two years later, the history of the material behind it is available without an investigation.
The specimen record lives in the governed data layer alongside the omics and clinical data it will eventually be joined to, which removes the reconciliation step that usually sits between a biobank and the science. Every change is attributable, timestamped, and immutable, aligned to 21 CFR Part 11 expectations and to ALCOA+ principles.
Because the audit trail is a property of the architecture, it does not depend on anyone remembering to record anything.
Data integrity findings in inspections are frequently about the traceability of material rather than about the analysis performed on it. A biobank operating to GxP has to demonstrate not only where a sample is, but who touched it, under what authority, and in what condition.
Axira sample management is designed to make that demonstration routine rather than a project.
Released in sequence, filings in progress.
Axira modules are released one at a time rather than as a single launch, each as a minimum lovable product that is complete enough to run on real work. This capability is the subject of intellectual property filings in progress. Its published name and its technical architecture are withheld until those filings complete, and detail is shared under a non-disclosure agreement.
By application.
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