Eine Vor­beu­ge­maß­nah­me könn­te zum Bei­spiel aus ei­ner OOT-Ana­ly­se re­sul­tie­ren. Hier ist es noch zu kei­ner tat­säch­li­chen Non­kon­for­mi­tät ge­kom­Males, aber es wur­de eine Ver­schlech­te­rung des va­li­dier­10 Pro­zes­ses fest­ge­stellt. Durch den CAPA-Professional­zess kann so­mit eine kon­t

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