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The scope is delimited to citations referencing 21 CFR 211.68(b) and associated observations pertaining to automated systems, computer systems, common login credentials, deficiencies in audit trails (including their absence or failure to review), and the deletion of electronic data
DOI: 10.1016/j.clnu.2017.04.002, Takakura, K., Koda, N., Kinoshita, Y., et al
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