Appteon supported CDRH’s Enterprise Architecture (EA) efforts by defining activities needed to be performed to mature its EA Program and support CDRH modernization efforts. Appteon identified the EA Program requirements that will support CDRH\’ governance processes; delineating actions that will need to be taken to develop, use, and maintain the EA including management control and oversight; addressing how the EA will be incorporated in the capital planning and investment process; establishing clear compliance criteria, processes and procedures to be used to document and specify how EA compliance will be determined and assured; providing subject matter expertise and support for new and evolving Federal EA guidelines, OMB 300 reviews and recommendations, including Federal Segment Architecture; and, making recommendations for FDA EA Program direction including organizational location, level of staffing and training necessary to develop program growth and institutional knowledge in the FDA community.
Appteon provided CDRH the initial capability to align existing and proposed IT initiatives with the FDA Enterprise Architecture. Appteon then proceeded to assess the progress and performance of IT investments in enabling the mission and provided information and recommendations to the CDRH Technical lead for IT investment management decisions.