Do We Qualify or Validate a Spectrometer?

Spectrometers have to be fit for their intended use; however, regulators separate analytical instrument qualification from computerized system validation. We critically review the qualification and validation approaches in the World Health Organization Technical Report Series (WHO TRS) 1019 Annex 3 and its applicability to spectrometer systems.

Authors

Mahboubeh Lotfinia
R.D. McDowall

Institutions

Roche (Switzerland) (CH)
Operation Wallacea (GB)

Publication Details

Journal: Spectroscopy
Published: 2024-12-01
DOI: https://doi.org/10.56530/spectroscopy.lz1286o2
Citations: 1
Primary Topic: Scientific Measurement and Uncertainty Evaluation
Type: article
Field-Weighted Citation Impact: 0.46

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article

Do We Qualify or Validate a Spectrometer?

Mahboubeh Lotfinia, R.D. McDowall

Dec 1, 2024

1 citations

Spectroscopy

Scientific Measurement and Uncertainty Evaluation

0.46

article

Do We Qualify or Validate a Spectrometer?

Mahboubeh Lotfinia, R.D. McDowall

December 1, 2024article en

1 citations

Abstract

Spectroscopy

Roche (Switzerland) (CH), Operation Wallacea (GB)

Openalex Percentile: Top 25%

Scientific Measurement and Uncertainty Evaluation

0.46

DOI Source OpenAlex

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Do We Qualify or Validate a Spectrometer? — Mahboubeh Lotfinia, R.D. McDowall · Spectroscopy (2024) | TGRS Research Map | TGRS