Long view of IT oversight

FDA eases OMB 300 reporting requirements with portfolio management software

Like all agencies, the Food and Drug Administration faces the challenge of getting a handle on its many IT purchases. These acquisitions stretch across numerous programs and dozens of technologies. To ease the task of understanding and analyzing such investments, FDA’s Office of the Chief Information Officer uses portfolio management software.

“The real, fundamental shift is that IT portfolio analysis has allowed us to move away from looking at individual investments [and toward] looking at investments in context of all the other IT work that is going on at FDA,” said Deborah Sholtes, who was working at the CIO’s office. (Since GCN’s interview, Sholtes has moved to FDA’s Center for Drug Evaluation and Research, helping that center define IT investment prioritization.)

The office had been working on alignment of the IT purchasing process with business goals since 1999. In particular, the office wanted to improve its own process of developing the agency’s annual Exhibit 300 submission to the Office of Management and Budget. The OMB Exhibit 300 details how how IT investments map with agency missions.

When done correctly, an Exhibit 300 can truly represent the agency’s investment management process. “If you have IT management policy practices and procedures in place in your organization, then your Exhibit 300 will show the evidence of that,” Sholtes said.

Achieving that level of clarity, however, can be quite a task. To correlate the data needed for a successful Exhibit 300 submission, the office had to cull information about dozens of different programs from hundreds of spreadsheets and documents.
“There was no real way to make that data meaningful,” Sholtes said.

For portfolio management, the office used ProSight Portfolios, and a number of related products from ProSight Inc. of Portland, Ore. The package can correlate all that Exhibit 300 information. Once all the input data is gathered, the software generates a full XML Exhibit 300 report, ready to submit to OMB. In addition, the software can channel the data through live executive dashboards, showing the metrics in pie charts, score cards and other data formats.

“Portfolio management is a set of processes and tools that manage the investments an organizations may make,” said Caine O’Brien, vice president of marketing for ProSight. “If you spend a half-billion dollars on an IT system, well, it better do something for the business. It better get results that are measurable.

What business processes does the IT support? And how does investment affect the expenses of those processes? If you propose a new project, how can you estimate a return of investment?” These are all questions that good portfolio management software should address.

For FDA, switching the data over to portfolio management software was initially a chore. Office personnel first took all the existing spreadsheets and documents and cut and pasted the information into the program. Since that first year, though, the information arrives at the data repository directly from the program officials themselves, because the data can be entered via Web browser.

Better than expected

Portfolio management helped streamline the process FDA used to create the Exhibit 300. Thanks to the software’s ability to group responses to specific questions, the office was able to “look at all the responses across the agency and do much more rigorous quality assurance than we were ever able to do, or even anticipated being able to do,” Sholtes said. The office could then focus on those areas—such as risk management—where answers had to be formatted in a specific way.

IT portfolio management went far beyond tidying up the Exhibit 300 process, though. The software also allows the office to double-check how well IT investments align with its own business goals. It also helps FDA make more strategic IT purchasing decisions.

“In the past, a very well respected individual would give a good presentation on a new technology, and everyone would say ‘Yes, that’s great.’ But when you look at any technology in the context of everything else, you really are able to focus on the impact to the organization and are less swayed by the influence of the presenter,” Sholtes said.

Portfolio analysis offers system architects more insight into what platforms the agency is using, and which are no longer being supported. For systems in place, the software allows them to determine how many instances of a soon-to-be-unsupported platform an agency has. It also provides a method to look for ways to unify technology platforms.

With portfolio management, the FDA can “better understand the strategic importance of IT,” Sholtes said.

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