As competition in the global marketplace intensifies, pharmaceutical manufacturers are under increased pressure to minimize inventory, lower costs, and introduce new products. To improve the operational effectiveness of the manufacturing and distribution process, they are aggressively implementing sophisticated levels of process automation. When implemented and integrated properly, these systems improve efficiency, provide more accurate forecasting and inventory tracking, and reduce manufacturing cycle time and cost.

However, these systems cannot be implemented in a vacuum. Regulated systems require robust life cycle management that begins with an analysis of the manufacturing workflow. The challenge is to first optimize business proccesses and then to develop a strategy for integrating the shop floor environment with electronic batch records, process scheduling technologies, and the company's strategic IT architecture. Key to the execution of this strategy is ensuring alignment between manufacturing and corporate IT strategies.

Because these automated systems directly impact product quality and patient safety, the FDA requires that they be developed, tested, commissioned, and maintained according to rigorous quality standards. In order to address these considerations in a manner consistent with the FDA's risk-based approach to compliance across systems, it is beneficial to create global program management offices. This structure will provide consistency and standardization of efforts across manufacturing and distribution systems that will in turn reduce drug manufacturing costs. increase efficiency, shorten time-to-market, and maintain regulatory compliance.