This customer develops pharmaceutical products based on advanced (inhalable and injectable) time release drug delivery systems. They have developed delivery systems for drugs that address medical disorders including schizophrenia, alcoholism, growth disorders, and diabetes.

Challenges
Of all drug candidates selected for development in the pharmaceutical industry, few make it to clinical trials. Fewer still go on to become successful and profitable products. With the odds stacked against them, pharmaceutical companies are now refining their business objectives to maximize their probability of success. In short, they must innovate faster, reduce risk, and increase profitability. Companies in the life sciences industry are under intense pressure to increase productivity and make research and development (R&D) more efficient. Companies face discovery and development cycles that often total 7 to 10 years, as well as development costs approaching US$800 million for each new drug. What’s more, costs are outpacing revenue from new products. In the last ten years, pharmaceutical spending on R&D has gone up 44 percent, but the number of blockbuster product launches has decreased by only 25 percent.

Solution
To ensure public health, federal regulations require all manufacturers to maintain secure and auditable trails of information pertaining to every phase of the development and manufacturing process. A framework that complies with the FDA’s 21 CFR Part 11 and cGMP regulations governing electronic records and e-signatures is built into the Oracle E-Business Suite.

For this multi-site pharmaceutical manufacturer, the implementation and upgrade activity took place in a fully-validated environment and included:

	Upgrade of corporate facility from older release of Oracle Financials and OPM and documentation for Sarbannes-Oxley compliance audit.
	New implementation of Oracle OPM at the main manufacturing facility CTE provided the business scripts as input for Operational Qualification (OQ)

Benefits
	Reduced risk
	Faster time to market
	Increased productivity