ULOQ QC (validation!) [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2011-12-22 15:22 (5299 d 19:18 ago) – Posting: # 7810
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Dear Ohlbe & Auditor!

❝ ❝ I have observed one procedure which is followed by one of the CRO during validation. While preparing QC samples from second weight […]



Shame on me. Two overlooked details.

❝ […] As such, I am not shocked to see a ULOQ QC 1 % above the upper limit of the calibration curve.


Agree. Since two weighings (aiming at ULOQ) are done nobody can expect to hit the ‘sweet spot’ all the time.

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