ADP Planning: FDA's Plans to Improve Processing of Medical Device and Drug Applications : Report to Congressional Requesters

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Page 1 - The Honorable Edward M. Kennedy Chairman, Committee on Labor and Human Resources United States Senate The Honorable Nancy Landon Kassebaum Ranking Minority Member Committee on Labor and Human Resources United States Senate The Honorable William D.
Page 13 - Specification is to specify for analysts and programmers the requirements, operating environment, design characteristics, and program specifications (if desired) for a system or subsystem.
Page 12 - Functional Requirements Document. The purpose of the Functional Requirements Document is to provide a basis for the mutual understanding between users and designers of the initial definition of the software, including the requirements, operating environment, and development plan.
Page 13 - Plan is to provide a plan for the testing of software; detailed specifications, descriptions and procedures for all tests; and test data reduction and evaluation criteria. Test Analysis Report. The purpose of the...
Page 14 - Manual is to provide the maintenance programmer with the information necessary to understand the programs, their operating environment, and their maintenance procedures. Test Plan. The purpose of the Test Plan is to provide a plan for the testing of software; detailed specifications, descriptions and procedures for all tests; and test data reduction and evaluation criteria.
Page 11 - ... alternative approaches. This document, in conjunction with the Feasibility Study Document, should provide the information for management to make decisions to initiate or continue the development, procurement or modification of the software system.
Page 2 - ... combination product does not preclude consultations by that component with other agency components or, in appropriate cases, the requirement by FDA of separate applications.
Page 11 - The purpose of this document is to provide: (1) an analysis of the objectives, requirements and system concepts; (2) an evaluation of alternative approaches for reasonably achieving the objectives; and (3) identification of a provides managers, users, designers and auditors with adequate coat and benefit information to analyze and evaluate alternative approaches.
Page 11 - Provides the means for a user organization to request the development, procurement, or modification of automated data systems or other ADP-related services.
Page 11 - May be supplemented with an appendix containing details of a cost/ benefit analysis, or may be considered with a separate cost/benefit analysis document.

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