On-Demand Information: The Future Is Now for Pharmaceutical Manufacturing

By the nature of the business, pharmaceutical manufacturers must observe many conditions and record much data. These procedures are critical to making safe and effective drugs and satisfying regulatory requirements.

David Besemer

Operational business intelligence (BI) is the on-demand capture and analysis of operational data at timely intervals for the purpose of taking immediate action to improve a business process. This technique differs from traditional BI, which involves trend analysis for longer-term planning. If an unplanned symptom or side effect is discovered by using operational BI tools, the shop floor supervisor can examine all critical data on the manufacturing process—even data from separate warehouse management and manufacturing systems—and quickly determine the location of the problem ingredients or compounds. Contaminated lots can then be found and recalled immediately.

In order to enable real-time, rapid data retrieval, operational BI works with a query-based integration technology called enterprise integration information (EII) that fulfills on-demand data aggregation requirements. EII provides an abstraction layer between information applications (e.g., BI and reporting tools) and the underlying data sources. EII collects disparate data sources, presents them in one place, and delivers the results to information dashboards, customer view portals, or other information applications. EII provides query caching and load balancing that can be integrated into the enterprise architecture. Operational BI with EII provides valuable, up-to-date information to plant managers, shop-floor supervisors, customer-service representatives, and salespeople.

Inventory management is one area of pharmaceutical manufacturing that can benefit most from operational BI. A key aspect of inventory control is maintaining enough ingredients to complete a production run and sufficient finished goods to fulfill customer orders. To ensure adequate supply, inventory levels must be monitored constantly, either manually or automatically. The goal is to have necessary ingredients available, thereby minimizing surplus inventory levels.

When EII technology is linked to a data warehouse and to various other data storage systems, inventory information is included in product warehouse business processes. This information enables companies to make real-time decisions as processing occurs, thus providing accurate information about stock levels. As a result, companies are better able to resolve storage and customer service issues, which helps avoid wastage of valuable ingredients that have short shelf lives.

Real-time data access has an additional benefit: pinpoint accuracy. It allows pharmaceutical companies to trace the ingredients used in individual products effectively. Then, companies can ensure that recipes have been compiled correctly and that errors are identified before defective products leave the factory.

EII improves plant capacity by enabling companies to determine quickly the stock levels of drugs or vaccines at all of their plants. It also can provide an inventory of the ingredients in each plant, thereby enabling companies to take immediate steps to increase production to fulfill new demands.

Operational BI also can help with compliance requirements. Information integrity is critical for compliance purposes, and companies need tight controls to track batch numbers and document the ingredients that go into each product. Some companies have found that older legacy systems can't keep up with demands. They may expend considerable effort to gather the required information manually. This process is costly and time-consuming and may delay the delivery of data to the proper regulatory body.

Because pharmaceutical manufacturing is becoming increasingly complex and businesses are under growing pressure for faster delivery of the highest quality products at competitive costs, operational BI with EII is an emerging technology poised to play an indispensable role.

David Besemer is the chief technology officer of Composite Software, 2655 Campus Drive, Suite 200, San Mateo, CA 94403, tel. 650.227.8200, david@compositesw.com