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Said: Have you reviewed the QC package insert? If 14% is within the CV specified in the QC package insert, you should be OK. However, you should also revise your validation/verification policy to accept the manufacturer's QC package insert CV...

Said: Thank you Erika, you are correct. It is just frustrating that the vendor doesn't raise the 14 percent CV as an issue to me, I had to read through the ep evaluator to bring it up to them. 

Said: That is exactly what I would do too, repeat the study. I always keep in mind that it is not the responsibility of the manufacturer to ensure we are compliant with our policies and accreditation standards. It is ours. 10 samples for tota...

Said: Thank you Erika for your speedy response. I'm not entirely fond of the technical field specialist from Werfen. The results that were posted were across 3 days with 10 points for that level. I can't exclude any as then it would be statis...

Said: It looks like you have all of the information you need at your fingertips. CV% can vary based on what your mean is and what 1SD is. Some institutions use a set acceptable %CV, like 5% or so, unless stated by the manufacturer (and FDA ap...