" /> Record - CISMeF





Preferred Label : Record;

NCIt definition : Anything (e.g., a document) providing permanent evidence of or information about past events.;

Alternative definition : CDISC-GLOSS: In a regulated environment, documented information in any format that is subject to the requirements for data integrity, and should be controlled and maintained. NOTE: The requirements for data integrity are covered by the ALCOA plus principles. [After 21 CFR Part 11, Parts 210, 211, and 212; 21 CFR 312.61 and 312.62] See also data integrity, ALCOA plus, electronic record, control of electronic records, EHR (electronic health record), electronic personal health record (ePHR), EMR (electronic medical record), trustworthy (electronic records), source data, source document.;

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30/07/2025


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