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The employee later recanted his statement, stating that he was not backdating records." Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)." 10 Detailed Analysis of the Violation Non-Contemporaneous Recording (Backdating): An investigator observed a laboratory employee "approving environmental monitoring records non-contemporaneously (or 'backdating')".10 While this involved a human action (signing a record for a past date), it implicates the computer system's inability to enforce contemporaneous recording

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(2014) 130:157988 10.1161/CIRCULATIONAHA.114.010389 [DOI] [PubMed] [Google Scholar] 67.Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, et al