Tech Success: FDA takes enterprise architecture medicine

Like every other federal agency, the Food and Drug Administration has been directed to improve its enterprise architecture and break down walls that isolate agency databases.The ultimate goal is to make information collected by FDA easily found, used and analyzed to let the agency more efficiently perform tasks such as tracking adverse reactions to drugs on the market.FDA brought in Blueprint Technologies Inc., Vienna, Va., to tackle the task of mapping the agency's enterprise architecture and provide the analytical tools to let FDA staff effectively use the data."FDA has done a good job at capturing its business knowledge," said Bernie Thuman, Blueprint's account manager for the FDA project. "What we've done is take that knowledge and put it into a central repository that can more efficiently facilitate decision-making."To accomplish that, Blueprint is using the Metis Enterprise visual modeling tool from Troux Technologies Inc. of Austin, Texas. The Metis tool was developed for commercial manufacturing processes, but has matured into a more diverse product, said Michael Carter, Metis product manager."Its main focus has moved toward the software modeling aspects of enterprise architecture," Carter said. "Many different government agencies are using it to create visual models of their enterprise architecture environment."At FDA, the visual model helps the agency track adverse drug reactions by letting it import, via an automated process, drug reaction data from any source. Before Metis was installed, data collected about a particular drug could have remained unused or lost in a data silo."Now, if there are bad reactions, [FDA] can categorize what those reactions are, and then connect those back up to the associated drugs," Carter said. "Or they can look at it the other way and see how many different drugs caused a specific type of reaction."What Metis does is let an organization see a large amount of data and easily drill down to access that data.It also provides the analytical capability to conduct research and find answers that wouldn't be possible using a tool like a relational database, Carter said."FDA officials could go into their architecture and say, 'What would be the impact of losing a particular server or data center,' " he said. "Then the software has the ability to traverse objects and relationships to determine the impact."Another FDA task Metis is helping with is the review and validation of drug applications submitted by pharmaceutical companies, Thuman said."With a drug application, there is a lot of internal activity that FDA goes through in terms of business workflow to approve or deny an application," he said.Metis creates a visual model of that business workflow and ties it back to FDA's IT system, letting FDA see if the process is running correctly and is accessing all needed data, Thuman said.In some cases, Metis can replace work that was done using other diagramming applications that focus solely on organizing complex processes. The Metis tools create diagrams, but also add the ability to intelligently query against the blueprints it creates.That function is useful when a large agency is trying to rid itself of siloed data. Metis can survey the IT environment and identify how assets interact, thus providing a way to assess redundancies and similar problems, Carter said.The system has also helped FDA connect its goals to its enterprise architecture."If FDA wants to spend $10 million on an application, they have to be able to map that back to those goals," Carter said. "They can say, 'By building this particular application, it's going to solve this particular problem or meet this particular goal.' And that's what the enterprise architecture does: It helps to marry things like application requests back to the architecture itself."Until it implemented Metis, FDA had no simple way to connect its business operations to its IT environment. FDA now can do impact analysis that once were impossible."If FDA wanted to change one of its business processes, we would be able to determine what in the IT environment would be impacted by that," Thuman said. "And it works the other way, too. If we wanted to make a change in the IT environment, like converting to another version of an operating system, you can then determine how that will impact a business process."If you have an innovative solution that you recently installed in a government agency, contact Staff Writer Doug Beizer at dbeizer@postnewsweektech.com.