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The ability to select only passing results is a hallmark of "Testing into Compliance." Risk to Patient Safety: The warning letter links "poor aseptic technique" with "data integrity lapses".15 The FDA required a risk assessment of "risks to patients caused by the release of drugs affected by a lapse of data integrity." This connects the abstract concept of "computer controls" to the concrete reality of "sterile" drugs potentially being contaminated due to manipulated production data

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[15] Hypersensitivity reactions including anaphylaxis or anaphylactoid reactions and allergic skin reactions may occur with tranexamic acid use

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