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(b) Reprocessing shall not be executed without the critique and approval of the quality Command unit.duties in the unbiased high quality device(s) really should not be delegated. These obligations need to be explained in writing and should involve, but not essentially be restricted to:Any departure from good distribution practice that brings about
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// I do not know how many observations you might be simulating. Regardless of whether It can be only some thousand, you would possibly get useful data from sample quantiles. I do not know a way to precise quantiles of an not known dist'n concerning indicate, var, skewness, kurtosis. If you have only a few hundred simulated values, I wonder ... $end