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Laboratory quality (OOS)
Track out-of-specification results and laboratory turnaround.
Quality & testingPharma & life sciences
How it's worked out
- OOS rate = OOS results ÷ tests. Invalidated rate = invalidated ÷ OOS
- One period
NoteA high share of invalidated OOS results is itself a warning sign of laboratory error, and regulators track it.
Source: FDA Guidance: Investigating OOS Test Results (2022); FDA Quality Metrics
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