LABORATORY DATA MANAGEMENT GUIDANCE - Out of Expectation (OOE) and Out of Trend (OOT) Results

Title:
LABORATORY DATA MANAGEMENT GUIDANCE - Out of Expectation (OOE) and Out of Trend (OOT) Results

https://www.gmp-compliance.org/files/guidemgr/ECA_AQCWG-SOP02-OOE-OOT_v1.2_July 2023.pdf

Origin/Publisher:

ECA Foundation

Content:
This document describes how to deal with Out of Expectation (OOE) and Out of Trend (OOT) Results in GMP regulated laboratories.

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