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[DOI] [PMC free article] [PubMed] [Google Scholar] 123.Singh B., Singh J

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Instead, they are organizational failure modes that emerge when executive leadership tolerates weak governance of computerized systems, when the Quality Unit (QU) lacks authority or competence to enforce controls, and when the Quality Management System (QMS) treats data governance as an IT topic rather than a core CGMP control

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Rigamonti AE, Casnici C, Marelli O, et al