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Confidence Statements in Process Validation by Armando Saldaña is a document available to read on EtoBox.

John Haury discusses using acceptance sampling and confidence statements to validate processes. He argues that validation reports should include quantitative confidence statements based on acceptance sampling plans rather than vague claims of "high confidence." Acceptance sampling relies on taking a representative sample of a production lot that is no more than 10% of the total lot size. The probabilities of accepting lots of different quality levels can then be determined based on the sampling plan used. C

Author

Armando Saldaña

Language

EN