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 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.