This paper outlines an initial investigation of the bio-pharmaceutical industry (BPI) and the steps it is taking to meet the new FDA risk mandate. It reviews the industry’s’ current strategy of improving its quality management systems that are central to achieving best practices within its operations. In addition the paper also reviews the strategy for upgrading to the next generation manufacturing execution systems which will control the enterprise facilities through full data integration and actionable intelligence.
"Pharmaceutical Risk Control Systems,"
Communications of the IIMA: Vol. 8
, Article 1.
Available at: http://scholarworks.lib.csusb.edu/ciima/vol8/iss2/1