Reasons for validating evaluation instruments

FDA's definition for Validation and relevant documentation - Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.It is essential that the validation process is documented and that the documentation is properly maintained.You go through some decision-making stages to help you with this part of your research proposal.On one level, the research process can appear to be relatively simple - if you carry out the basic steps methodically and carefully, then you should arrive at useful conclusions.In a study of computer-assisted writing classrooms, Snyder (1995) employed both qualitative and quantitative approaches.The study was constructed according to guidelines for quantitative studies: the computer classroom was the "treatment" group and the traditional pen and paper classroom was the "control" group.

The purpose of the collected data must be clear, it must reflect facts and be accurate.Approval and release of the process for use in routine manufacturing should be based upon a review of all the validation documentation, including data from the equipment qualification, process performance qualification, and product/package testing to ensure compatibility with the process.For routine production, it is important to adequately record process details such as information on the equipment, ambient environment/temperature, etc. Maintaining a log to input data periodically is useful in tracking performance and identifying causes for failure.It is important that you understand all the various ways of collecting data so that you can decide which to use for your own research.It is also worth remembering at this stage that all methods of data collection can supply quantitative data (numbers and statistics) or qualitative data (usually words or text).The protocol should specify a sufficient number of replicate process runs to demonstrate consistency in results and measure any process variations between runs.

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