ADP Systems:

FDA Can Reduce Development Risks for Its Import Information System

IMTEC-88-42: Published: Sep 30, 1988. Publicly Released: Oct 19, 1988.

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In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) automated Import Support and Information System (ISIS) to determine whether FDA: (1) complied with government standards and regulations in developing ISIS; (2) ensured that ISIS would interface with the Customs Service's automated systems; (3) plans to use ISIS to collect data on imports FDA regulates; and (4) ensured that ISIS would be compatible with existing management systems.

GAO found that FDA: (1) failed to follow government standards requiring competitive procurement of computer systems, system design, and interface requirements; (2) did not identify alternative system designs for management consideration; (3) postponed identifying interface requirements until after the system becomes operational; (4) plans to use ISIS to collect data only for those imports examined at the port of entry; and (5) believes that ISIS will be compatible with existing automated systems, such as the Laboratory Management System. GAO noted that, if FDA fails to identify and plan for its interface requirements, ISIS may be unable to interface with Customs' systems.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In order to comply with this recommendation, FDA withdrew an earlier agency procurement request and submitted a new agency procurement request for ISIS in functional terms timed to coordinate the equipment acquisition with completion of the pilot test, which began October 1, 1990.

    Recommendation: The Secretary of Health and Human Services should take steps to ensure that FDA complies with department requirements to identify and specify FDA computer hardware and software requirements for ISIS in functional terms, rather than specifying vendor-specific computer hardware and software.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: On October 19, 1992, FDA and Customs implemented the pilot automated interface project with the initial testing of the Seattle Electronics Entry Project. FDA indicated that it would not make any further reports on this recommendation.

    Recommendation: The Secretary of Health and Human Services should take steps to ensure that FDA complies with department requirements to identify FDA requirements for an ISIS automated interface with Customs, and obtain an agreement on a plan to implement the automated interface.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: The FDA contractor delivered a cost-benefit analysis that addressed four alternative hardware configurations for ISIS. The Associate Commissioner for Regulatory Affairs selected one alternative and issued a decision in June 1989 to support the system with decentralized mini-computers in each region. Office automation and access to the primary data systems will be achieved.

    Recommendation: The Secretary of Health and Human Services should take steps to ensure that FDA complies with department requirements to explore feasible alternative system designs to meet the functional requirements of ISIS.

    Agency Affected: Department of Health and Human Services

 

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