Reasons For Validation
Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification
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Famous quotes containing the words reasons for and/or reasons:
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—George Eliot [Mary Ann (or Marian)
“The source of Pyrrhonism comes from failing to distinguish between a demonstration, a proof and a probability. A demonstration supposes that the contradictory idea is impossible; a proof of fact is where all the reasons lead to belief, without there being any pretext for doubt; a probability is where the reasons for belief are stronger than those for doubting.”
—Andrew Michael Ramsay (1686–1743)