Process Validation of Existing Processes and Systems Using Statistically .Part3

Andrew W. Jones, Technical Manager, KMI/PAREXEL LLC
ISPE, September 2001 Determine the Confidence Interval as compared to +/- 3S.D. With the +/- 3 S.D. ranges determined, it can be considered important to evaluate what confidence there is that the next data point will fall within this range. The rationale for determining this level is to justify that the +/- 3 S.D. range provides a confidence that 99% of the data is within that range. Similar to the +/- 3 S.D. range, the confidence interval is a range between which the next measurement would fall. This level is typically 99% or greater. Thus a 99% confidence interval means, "there is 99% insurance that the next value would be in the range."

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Andrew W. Jones, Technical Manager, KMI/PAREXEL LLC
ISPE, September 2001

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