invitro_spain
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The terms OOS and OOT always emerge in connection with the handling of deviating analysis results during Quality control processes. Both terms have the following definitions:
Out-of-Specification (OOS) Results
A result that falls outside established acceptance criteria which have been established in the Company SOPs.
Out of Trend (OOT) Results
A time dependent result which falls outside a prediction interval or fails a statistical process control criterion.
A trend is a sequence of temporal procedures, e.g. for the manufacture of different batches of a product. There are two types of trends:
Out-of-Specification (OOS) Results
A result that falls outside established acceptance criteria which have been established in the Company SOPs.
Out of Trend (OOT) Results
A time dependent result which falls outside a prediction interval or fails a statistical process control criterion.
A trend is a sequence of temporal procedures, e.g. for the manufacture of different batches of a product. There are two types of trends: