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Morgan GERMA: Collaborator at Joseph Fourier University, Grenoble, Master CQAQMV
INTRODUCTION
Based on observed data, the only tangible and sincere proof of established and controlled quality, validation will provide you with proof through experience.
However, to validate, you must first :
the same language (validation is at the crossroads of quality, metrology, statistics and human factors);
good methods (risk analysis, equipment qualification, performance monitoring);
the right tools (experimental designs, control charts, sampling rules, etc.).
The field of validation is vast and offers many opportunities for improvement.
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Validation of analytical methods
Bibliography
ISO Standard 3534-1 Statistics – Vocabulary and symbols, Part 1: General statistical terms and terms used in probability calculations
ISO 3534-2 Statistics – Vocabulary and symbols, Part 2: Applied statistics
ISO 3534-3 Statistics – Vocabulary and symbols, Part 3: Experimental designs
Analytical validation...
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