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John Helfrich is the director of GMP automation programs at VelQuest Corporation, where he is involved in the method translation understanding of QC lab test methods and the production SOPs to the software conventions used in the VelQuest GMP Electronic Notebook platform.
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.