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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.
Complex User Interfaces: Many legacy systems had cumbersome and outdated user interfaces that were not user-friendly. This complexity made it difficult for trial managers and site staff to navigate the system efficiently, leading to potential errors and reduced productivity.
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