“…In meeting our public health mission, the FDA must have more effective and efficient business processes, increased capabilities to better use the data that we review, and a more coordinated development of the IT systems designed to support these activities. In the past, the FDA has taken an organization-based approach to process development and IT investments, resulting in siloed solutions and a fragmented data environment. To achieve new efficiencies, the FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.”
“The Enterprise Modernization Action Plan
Today we are introducing the Enterprise Modernization Action Plan (EMAP), which is the next phase of the FDA’s stronger data and technology foundational approach, which began in 2019, with the Technology Modernization Action Plan (TMAP) followed by last year’s Data Modernization Action Plan (DMAP). Our IT and data modernization efforts form a strong foundation for the future, and will continue to evolve: changes at the data and technology levels must be accompanied by improved business operations to achieve our goals. The EMAP describes our plans to shape the FDA’s future by delivering successful cross-agency efforts that optimize common and essential business processes. We will do this work methodically, ensuring we are solving the right problems, with the right team, to produce measurable results. These efforts will improve operational efficiency and the use of data while strengthening the alignment between agency-wide strategic objectives and investments.”
“The three components of the EMAP are to:
- Create the Infrastructure to Support Change: The Enterprise Transformation Operation (ETO) team was created within the Office of the Commissioner and strategically reviews enterprise-wide challenges and implements optimized business processes. The ETO is governed by a committee of the agency’s senior leadership charged with prioritizing the most pressing priorities and change opportunities.
- Develop a Common Operational Approach: The ETO will employ a standardized approach to analyze, recommend, and implement agreed-upon enterprise business programs that solve shared, cross-agency issues by optimizing business processes and use of data across multiple centers and offices.
- Ensure Strategic Alignment: Improving alignment between agency-wide strategic objectives and program activities will help us effectively manage funding to increase the return on investment and improve operational and employee effectiveness and efficiency.” Read the full article here.
Source: FDA’s “All-in” Approach to Enterprise Transformation – By Janet Woodcock, M.D. and Meredith Chuk, M.D., May 19, 2022. FDA.
