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[1] Additionally, the product should be stored out of reach of children

10.1002/(SICI)1097-4547(19970315)47:6 3.0.CO;2-Z 9 AntonicA.DottoriM.MacleodM

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DOI: Received: Accepted: Published: Publisher Name: Springer, Cham Print ISBN: 978-3-319-27317-4 Online ISBN: 978-3-319-27317-4 eBook Packages: Living Reference MedicineReference Module Medicine

Remediation: The Independent Assessment: The FDA mandated a "comprehensive, independent assessment of all laboratory computer systems".4 This requirement for an independent assessment underscores the agency's lack of confidence in the firm's internal IT and QA competence