FDA Import Automation: Serious Management and Systems Development Problems Persist : Report to the Ranking Minority Member, Committee on Commerce, House of Representatives |
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addition ADP hardware ADP Systems automated import system automated interface best practices business processes conducting a cost-benefit conducting user acceptance contingency plan cost and performance cost-benefit analysis deployment Deputy Commissioner design review committee EEPS ensure Entry Process expertise FDA districts FDA import FDA inspectors FDA Review Human Services import brokers import entries Import Information System import operations Import Support improved information management Information Resources Management information technology interface with ACS interface with Customs Management and Systems OASIS project manager OASIS System Office of Management Office of Regulatory OIRM ORA's performance information Pesticide Monitoring pilot test practices of leading ready for national requirements requirements analysis resolved if FDA risk assessment Seattle District security plan self-assessment report self-assessment team senior-level management shipment Software development contractor strategic information systems submit entry documents Support and Information system design review systems development problems systems development procedures telecommunications user acceptance testing
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Page 18 - We will then send copies of this report to the Secretary of Health and Human Services, the Commissioner of the Food and Drug Administration, the Director of the Office of Management and Budget, and others who are interested.
Page 12 - ... the OASIS project and monitor the contractor's work. A best practice that can lead to improved mission performance is to ensure that skills and knowledge of line and information management professionals are upgraded. Also useful is establishing customer/ supplier relationships internally and defining roles between line managers and information management support professionals to maximize management processes. Lastly, the chance of a breakdown between the agency and contractors is great when the...
Page 1 - Control (CDC), a part of the Public Health Service (PHS) within the Department of Health and Human Services (HHS...
Page 4 - Executive Guide: Improving Mission Performance Through Strategic Information Management and Technology (GAO/AIMD-94-1 15, May 1994).
Page 14 - Publication 38, Guidelines for Documentation of Computer Programs and Automated Data Systems, National Technical Information Service, Department of Commerce.
Page 6 - Jury -October 1995 Contractor completed feasibility study of an import system. FDA Commissioner formed the National Import Data System Task Force to design an import system. Software development contractor hired to develop an import system, known as the Import Support and Information System (ISIS), without an interface with Customs' Automated Commercial System (ACS). ISIS was pilot tested in Boston, Massachusetts, and Buffalo, New York. Test results called for an automated interface with Customs'...
Page 11 - Officer designated under paragraph (2) shall head an office responsible for ensuring agency compliance with and prompt, efficient, and effective implementation of the information policies and information resources management responsibilities established under this chapter, including the reduction of information collection burdens on the public.
Page 9 - FDA'S Efforts To Improve Import Monitoring and Enforcement (GAO/T-RCED-93-55, June 16, 1993). and appropriate resources needed to support the project. We found that this situation was largely due to an IRM structure that did not clearly define control and lines of accountability for the OASIS project. In addition, we found that the OASIS project was directed by managers who lacked the systems...
Page 16 - New business processes should then be designed and the organizational culture, l4This estimate included (1) nonrecurring costs for systems development and implementation, ADP hardware and software, and training and (2) recurring costs for ADP hardware and software, telecommunications, systems operations, the interface with Customs. Also, the contractor's estimate identified an additional $351 million in recurring costs for FDA import personnel FTEs during this period.
Page 13 - ... analyses—typically modeling sensitivities of project outcomes to various risk factors-underpin the criteria. The investment focus systematically reduces inherent risks while maximizing benefits of complex projects. It does so by concentrating top management's attention on assessing and managing risk and regulating the tradeoffs between continued funding of existing operations and developing new performance capabilities. These tradeoffs, as well as conflicts between competing programs, surface...