SOCRA CCRP Practice Exam

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What FDA regulations apply to electronic records and signatures for a closed system?

21 CFR 11
42 CFR 2
18 CFR 225
36 CFR 119

The correct answer is: 21 CFR 11

Electronic records and signatures for a closed system are subject to FDA regulations outlined in 21 CFR 11. This regulation ensures the security, authenticity, and reliability of electronic records and signatures used in FDA-regulated industries. Option B, 42 CFR 2, pertains to confidentiality of substance abuse treatment records. Option C, 18 CFR 225, relates to emergency actions to ensure electric reliability. Option D, 36 CFR 119, deals with data security and privacy for non-public information. Therefore, these options are not relevant to the regulations for electronic records and signatures specified in the question.