Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2021-10-18 08:35 (216 d 14:16 ago) – Posting: # 22632
Views: 1,226

Hi quallityassurance,

» What if we have 12 QCs in run (3 replicates of each Low, Low-mid, Mid and High) and 1 replicate of each Low, Low-mid, Mid and High failed leading to pass 66.67% of QCs (8 out of 12).
»
» May we accept the analytical run and considered as pass? :confused::confused:


I think the run passed when 2/3 were ok.
I agree the wording leads to some confusion but here you should be ok. 2/3 in unrounded percent is 67. :-)

Pass or fail!
ElMaestro

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