Focus On Quality: Validation of Spectrometry Software: Applying an Integrated Approach to Equipment Qualification and Computerized System Validation

摘要

An integrated approach to the qualification of a near-infrared spectrometer combined with the validation of the controlling software is outlined in this column. In the last column (1), I outlined a suggested process for the integration of equipment qualification and computerized system validation for a spectrometer. In this column I would like to describe how this process should be used in practice with a near-infrared (NIR) spectrometer and computer system for the identification of raw materials in a manufacturing environment.