1. Going beyond method validation
At the beginning of the 20th century, nobody really questioned the "validity" of an analyst's results. Famous examples of criminal cases illustrate the omnipotence of the toxicologist-analysts of the time, who could refuse to explain how they obtained their measurements. The major industrial chemical accidents of the 1960s (Minamata, Seveso, etc.), or the traumatic thalidomide episode for the pharmaceutical sciences, demonstrated the potential of analytical chemistry as a tool for protecting public health. As a result, civil society and/or the judiciary began to question the basis of analytical results. The question of the reliability of the values provided was quickly raised, and the role of analysts changed as skepticism grew. At the turn of the 1980s, in response to the often legitimate questions raised by those receiving results, quality systems such as accreditation and good laboratory...
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Going beyond method validation
Bibliography
Standards and norms
- Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais - NF EN ISO/IEC 17025 - 2017
- Lignes directrices relatives à l'utilisation d'estimations de la répétabilité, de la reproductibilité et de la justesse dans l'évaluation de l'incertitude de mesure - ISO 21748 - 2017
- Analysis of agricultural and food products – Characterization protocol to validate a quantitative analysis...
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