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The citation notes "observed lapses, including but not limited to laboratory controls, documentation practices, and data integrity controls".1 Systemic Oversight Failure: The violation was not characterized as a localized instrument failure but as a "fundamental weakness in the QUs oversight function".1 The Quality Unit (QU) is charged with the responsibility of ensuring that systems are validated and secure

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Despite overlapping benefits, growing evidence suggests that these agents have distinct and complementary roles in clinical practice