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Who Exactly Owns Quality?
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By Eric Hinrichs, Ethicon, part of the Johnson & Johnson Medical Device Companies
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We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.
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You Can't CAPA What You Can't Classify
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By Kayla Britt, Britt Biocomputing
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An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
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