Case study · Laboratories

Full result traceability for ISO 15189

Every result is tied to the method version, analyser and reagent lot; an analyser past calibration cannot post results.

Client: A medical laboratory · System: Vitrio ERP

221/221
tests passing
7
new traceability controls

The challenge

Accreditation requires proving where every result came from: which method, analyser and reagent, and whether the analyser was calibrated.

What we built

  • A calibration guard that blocks results from an out-of-date analyser.
  • Method version, reagent lot and uncertainty stored with every result.
  • A certificate of analysis with a verification code, and sample chain of custody.
  • A print audit trail plus password and idle-session policies.

The result

The lab can show an auditor the origin of any result from one screen.

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