Our premise is that functional organizations, namely Production, Quality and Information Technology, have traditionally solved problems by rapid problem definition, solution design and implementation of automated controls or other computer systems. The new economy represents a new set of challenges to that approach. These challenges take the form of worldwide production and distribution, cost pressures, site consolidation and more stringent FDA requirements. Meeting these challenges requires a new method of problem solving in the areas of manufacturing and quality control. This will also have a significant impact on the roles and responsibilities of the Information Technology (IT) organization in supporting these two organizations. This paper is based on consulting work that dealt with the overall business transformation associated with management and control of batch records while improving operating efficiency and reducing risk.
Author: Patrick Hurley, Principal, Cap Gemini Ernst & Young | File Type: PDF
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