PAT Initiatives for QC/QA Operations: Enabling Paperless Processes for Manufacturing Batch Records and QC Laboratories

This paper outlines the current situation in manufacturing and quality operations relative to industry compliance initiatives and manufacturing challenges. It profiles an innovative ?method-centric? software platform, designed for the analyst or operator, to electronically execute and man-age quality control testing protocols and production batch records, yielding significant reductions in overall product release cycle time.