A comprehensive approach to method validation based on object technology

Method validation procedure requires a strategy for collecting those validation data that are best adapted to the analytical technique used. A flexible and general approach based on Object Linking and Embedding technology is proposed. It allows a traceable validation strategy using modular objects w...

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Veröffentlicht in:Accreditation and quality assurance 1997-03, Vol.2 (2), p.69-75
Hauptverfasser: FEINBERG, M. H, GERBANOWSKI, A, RUTLEDGE, D. N
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container_title Accreditation and quality assurance
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creator FEINBERG, M. H
GERBANOWSKI, A
RUTLEDGE, D. N
description Method validation procedure requires a strategy for collecting those validation data that are best adapted to the analytical technique used. A flexible and general approach based on Object Linking and Embedding technology is proposed. It allows a traceable validation strategy using modular objects which encapsulate documentation, analytical data and processing logic. The contents of these objects are accessible through a standard user interface. This paper demonstrates how this can reduce experiment time, simplify evaluation efforts, and increase the ease of use of validation figures of merit. An illustration using Microsoft Visual Basic for Applications is presented, and some specific aspects are described. It consists of the evaluation of a time domain NMR technique for determining the moisture content of foods involving a multivariate calibration step. This study also illustrates how guidelines such as Good Validation Practices could be defined to present all validation documents in a standardised manner.
doi_str_mv 10.1007/s007690050101
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subjects Analytical chemistry
Biological and medical sciences
Chemistry
Exact sciences and technology
Figure of merit
Food industries
Fundamental and applied biological sciences. Psychology
General aspects
General, instrumentation
Life Sciences
Methods of analysis, processing and quality control, regulation, standards
Moisture content
NMR
Nuclear magnetic resonance
Time domain analysis
Visual Basic for Applications
title A comprehensive approach to method validation based on object technology
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