FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts : Report to Congressional Requesters
The Food and Drug Administration (FDA) relies heavily on information technology (IT) to carry out its responsibility for ensuring the safety and effectiveness of certain consumer products. Recognizing limitations in its IT capabilities that had been previously identified in studies by FDA and others, the agency has begun various initiatives to modernize its IT systems. GAO was asked to (1) evaluate the agency's overall plans for modernizing its IT systems, including the extent to which the plans address identified limitations or inadequacies in the agency's capabilities, and (2) assess to what extent the agency has put in place key IT management policies and processes to guide the implementation of its modernization projects. GAO analyzed FDA's plans to determine whether they followed best practices and addressed capability limitations, reviewed key management policies and processes, and interviewed agency officials. GAO is recommending that FDA expeditiously develop a comprehensive IT strategic plan, give priority to architecture development, and complete key elements of IT human capital planning.
[Washington, D.C.] : U.S. Govt. Accountability Office, 
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ii, 52 p. : digital, PDF file