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:
“With no matter what human being, taken individually, I always find reasons for concluding that sorrow and misfortune do not suit him; either because he seems too mediocre for anything so great, or, on the contrary, too precious to be destroyed.”
—Simone Weil (1909–1943)
“With no matter what human being, taken individually, I always find reasons for concluding that sorrow and misfortune do not suit him; either because he seems too mediocre for anything so great, or, on the contrary, too precious to be destroyed.”
—Simone Weil (1909–1943)