Function and Performance Specification

Preliminary selection of the functional and performance specifications (technical, environmental, safety)... [Pg.259]

Final selection of the equipment, functional and performance specifications Final selection and qualification of the supplier... [Pg.259]

To set the functional and performance specifications, the vendor s specification sheets can be used as guidelines. However, it is not recommended that the vendor s specifications simply be copied because compliance to the functional and performance specifications must be verified later, during operational qualification and performance qualification. Specifying too many functions and/or setting the values too stringently will significantly increase the workload for OQ. [Pg.260]

Design qualification (DQ) covers setting of user requirements, as well as functional and performance specifications. Design qualification should ensure that the instrument has aU the necessary functions and performance criteria that will enable it to be successfully used for the intended application. Design qualification includes 1) Description of the intended use of the equipment 2) se-... [Pg.1691]

Operational qualification, or acceptance testing, is the process of demonstrating that the whole instmment or its modules will function according to its operational specification, in the selected environment, according to previously defined functional and performance specifications ( acceptance criteria ). This procedure can be performed to the extent of the self-diagnostics routine test or to a more detailed procedure regarding flow-rate, injector precision, or wavelength accuracy. It can be carried out by the user or the vendor on behalf of the user. [Pg.1692]

Design qualification (DQ) for setting functional and performance specification (operational specification)... [Pg.25]

Operational qualification (OQ) for testing the equipment to ensure that it meets the previously defined functional and performance specifications... [Pg.25]

Fortunately, however, existing computerized systems have an advantage over new systems experience gained over time. Most computer systems in analytical laboratories have been tested in one way another, for example, the vendors functional and performance specifications may have been verified when the system was installed, or the complete system may have been tested for suitability on a day-by-day basis. In the validation process, the evaluator can use this experience and test results to review and assess the quality of analytical results from computer systems. Such a review and its... [Pg.52]

Specification and user documentation of the pre-developed software shall be available, defining explicitly all characteristics that are relevant in fulfilling the systems functional and performance specifications. lEC 60880-2 (Cat. A)... [Pg.62]

Function and Performance Specification (FPS), which provides the solution (acquisition) requirements and... [Pg.35]

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