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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.
Cloud-based platforms enable seamless collaboration among stakeholders, including sponsors, CROs, site staff, and regulatory bodies, ensuring that everyone has access to the most up-to-date information at all times. The result is improved data accuracy, reduced redundancy, and a comprehensive view of trial progress.
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