ABSTRACT
INTRODUCTION Process analytical technologiesa (PAT) provide “systems for analysis and control of manufacturing processes based on timely measurements during processing of critical quality parameters and performance attributes of raw and in-process materials and processes to assure acceptable end product quality at the completion of the process” (1). As such PAT offers higher manufacturing efficiency, but requires a change in the established quality paradigm from analytical quality control on finished goods to a practice of a true process quality assurance philosophy. This case study will look at the implications for supporting computer systems.
