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Lot or Batch definition for IVDs

Posted 1st August 2018 at 03:35 AM by invitro_spain

US Regulation (21 CFR Part 820 (m))
Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that is manufactured under essentially the same conditions and...
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What is the difference between OOS/OOT

Posted 1st February 2018 at 06:54 AM by invitro_spain

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...
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