ABSTRACT

Process Analytical Technologies (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 QC on finished goods to a practice of process QA philosophy. This brief case study considers the implications for supporting computer systems.