Mastering 21 CFR Part 11 Compliance: A Comprehensive Guide for Clinical Trials in the Digital Age
Cloudbyz
JUNE 10, 2023
21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. The regulation was established in 1997 to address the FDA’s concerns regarding the use of electronic records and signatures, ensuring their integrity, accuracy, and confidentiality.
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