21 CFR Part 11 refers to the regulations established in Title 21 of the Code of Federal Regulations (CFR) Part 11, which govern the use of electronic records and electronic signatures in systems subject to oversight from the United States Food and Drug Administration (FDA). These regulations were developed to ensure the reliability, integrity, authenticity, and trustworthiness of digital records as life sciences and regulated industries transitioned from paper-based to computerized systems. Part 11 specifies criteria for electronic records to be considered equivalent to paper records and for electronic signatures to be legally binding.
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