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Laboratory and Validation

Diagnostic Centre Calibration Compliance Program

A diagnostic centre needed calibration and validation records for laboratory equipment before an external quality review.

Anonymized case study

Project background

A diagnostic centre needed calibration and validation records for laboratory equipment before an external quality review.

This representative case study is written for hospitals, diagnostic centres, biomedical engineers and quality teams planning calibration, preventive maintenance, validation, electrical safety testing or audit documentation.

Approach

  • Reviewed laboratory equipment by process and risk.
  • Completed calibration, mapping or validation as applicable.
  • Matched certificates to equipment identity and location.
  • Prepared a record file for quality review.

Outcome

  • Laboratory documentation was more complete.
  • Due dates became easier to monitor.
  • Temperature and measurement equipment records were clearer.

Equipment involved

  • Micropipettes
  • Centrifuges
  • Incubators
  • Refrigerators

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