Organizations accruing benefits from Oracle manufacturing solutions include Colorcon; Teva Pharmaceutical Industries, Ltd.; Hologic, Inc.; Three Rivers Pharmaceuticals, LLC; and Cubist Pharmaceuticals, Inc. In addition, New York-based Eyetech Pharmaceuticals, Inc., a company that develops therapeutics to treat eye diseases, and Telik, Inc., a Palo Alto, Calif.-based biopharmaceutical company that develops drugs to treat cancer and other serious diseases, recently selected Oracle Process Manufacturing to integrate manufacturing processes and facilitate regulatory compliance.

Improving Quality and Inventory Management
Colorcon -- a global manufacturer that develops specialty products for the food and pharmaceutical industries -- relies on Oracle Process Manufacturing as well as other Oracle E-Business Suite applications to improve quality and inventory management. These applications allow the West Point, Penn.-based company to ensure confidence in the consistency and validity of its global production and supply-chain processes, as well as those of its key suppliers. With Oracle applications, Colorcon has also cut its production lead time in half, elevated inventory management and accuracy and improved its ability to provide and follow up on its overall sales process.

Prior to implementing Oracle Process Manufacturing, Colorcon leveraged several non-integrated management systems. As a result, the organization lacked visibility across its global manufacturing operations, forcing it to spend significant time, effort and resources to ensure a consistent methodology for formulations as well as uniform manufacturing processes across its various production facilities.

"As a supplier to the pharmaceutical industry, we must comply with stringent regulations, many of which require extensive documentation of our manufacturing and supply-chain processes," said Perry Cozzone, chief information officer, Colorcon. "Oracle has made a significant effort in its process manufacturing module to recognize validation and regulatory requirements - including 21CFR Part 11, which requires companies to employ procedures and controls to ensure the authenticity, integrity and, when appropriate, the confidentiality of electronic records. Oracle provides effective tools and extensions that enable organizations like ours to accelerate validation and compliance processes."

Recently, Colorcon implemented a barcode solution integrated with Oracle Process Manufacturing to facilitate mobile wireless transactions throughout its manufacturing process, primarily for data entry around batch management, batch processing, material movement, material receipt and material tracking.

Managing Production in a Dynamic Environment
Teva Pharmaceutical Industries Ltd., the largest generic-drug maker in the United States and the world, deployed Oracle E-Business Suite Process Manufacturing to manage its dynamic organizational structure, maximize supply chain efficiencies and comply with strict regulatory compliance requirements. The company fuels its global growth via an ambitious acquisition strategy. In the last 25 years, it had acquired and merged more than one company a year. Consequently, Teva has built a complex internal structure of business units, geographical units and divisions. Visibility across the organization and its supply chain is critical to Teva. It must also be able to rapidly roll out new modules across its diverse organization. Teva runs Oracle Process Manufacturing inventory management applications, as well as other components of Oracle E-Business Suite, to manage order to cash, procure to pay, forecasting, trade management and advanced supply chain planning business flows at several sitesin North America. It continues to roll out Oracle E-Business Suite modules as the foundation of its global infrastructure.

"Oracle provides us with true worldwide and local support service, including support for our operations in Israel," said Isaac Gilboa, chief information officer, Teva Pharmaceuticals. "It has also demonstrated a corporate-wide strategic commitment to the pharmaceutical industry and a willingness to collaborate with us on future software design efforts. We believe that Oracle's strategic vision to invest in product development with direct input from the pharmaceutical industry provides us with an advantage over many competitors."

Delivering Quality and Control
Hologic, Inc. -- a leading developer, manufacturer and supplier of medical imaging systems dedicated to serving the health needs of women -- has improved the efficiency of its global manufacturing processes from initial design and engineering through work-in-process to cost management with Oracle Discrete Manufacturing. In addition, Hologic, headquartered in Bedford, Mass., recently implemented Oracle Quality, which has expanded its ability to track and trend defects, ultimately improving customer service.

"With Oracle, we have automated our processes for tracking corrective and preventive actions and compiling supplier ratings," said Dave Rudzinsky, chief information officer, Hologic. "We used to track this information manually and store it in stand-alone systems, which did not give us full visibility across our suppliers. We can now integrate and trend the information, allowing us to rapidly and effectively address quality issues with our suppliers."

Hologic continues to expand its Oracle implementation, most recently piloting Oracle Mobile Field Service, an application that empowers technicians with the most current and actionable information to efficiently resolve onsite service requests and expedite billing.

Enhancing Visibility Across the Manufacturing Process
Three Rivers Pharmaceuticals, LLC -- a Pennsylvania-based, privately owned pharmaceutical company that develops and markets prescription drugs -- implemented Oracle Process Manufacturing to create a technology infrastructure that enables the organization to effectively track compliance with complex FDA requirements while streamlining production processes. It also required a solution that would help it coordinate manufacturing and financial data with its international partners, contract manufacturers and research organizations.

Most recently, Three Rivers Pharmaceuticals purchased Oracle Quality and has begun to implement processes with electronic data interchange (EDI) gateway applications. The organization can now store all quality-related data in a single location, improving its ability to identify and respond to quality issues, and streamline the documentation process. Oracle presents information in forms and reports that meet corporate requirements.

"The various components of Oracle's manufacturing and financial modules integrate seamlessly, making for a smoother implementation and overall reliable data," said Christine Sheehy, vice president of operations, Three Rivers Pharmaceuticals. "We can now effectively and efficiently track product and forecasting data at very detailed levels, a critical requirement in our highly regulated and competitive industry."

Three Rivers outsources management of its Oracle Database and applications with Oracle On Demand, allowing the organization to reduce its IT budget by cutting the full-time accounts payable job to half time and deploying employees to new tasks. It has saved $400,000 per year on staffing costs and an additional $350,000 on hardware, software and maintenance costs. These savings enabled Three Rivers to cut its annual IT budget by 40 percent.

Facilitating Regulatory Compliance
Cubist Pharmaceuticals, Inc. -- a biopharmaceutical company focused on the research, development and commercialization of products that address unmet medical needs in the acute care environment -- implemented Oracle Process Manufacturing to facilitate regulatory compliance related to pharmaceutical manufacturing processes and improve its ability to rapidly and effectively respond to FDA inquiries. Cubist, which leverages contract manufacturers, uses Oracle Process Manufacturing for lot tracking and genealogy across its various contractors. The organization also uses the system to evaluate the performance of its contractors in developing products that meet standard industry tolerances. Cubist stores all data in a single database, which provides visibility across the organization and its contract firms for ease in responding to inquiries regarding specific lots.

Oracle Process Manufacturing has also improved Cubist Pharmaceutical's ability to monitor and control inventory. "We run a single transaction on a daily basis, which pulls the number of sales and automatically reduces the number of vials sold from our inventory," said Anthony Murabito, vice president, information technology, Cubist Pharmaceuticals. "The system also integrates with Oracle Financials, allowing us to track raw materials going into inventory and register finished product as an asset on our books. Today, we are expanding our Oracle Process Manufacturing solution across additional manufacturing and packaging sites."

Cubist recently implemented Oracle Database Lite to support deployment of an automated sales tool that improves productivity and efficiency. "We chose Oracle Database Lite because it is Web-ready and complements our existing Oracle footprint," said Kelly Schmitz, director of application development and production, Cubist. "We can remotely distribute new applications using the same processes that our sales representatives use when updating data. It also allows us to roll out changes uniformly to our entire sales team in minutes using industry standards."

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