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Tripwire and 21 CFR Part 11: Ensuring Integrity and Trustworthiness of Electronic Clinical Data

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Executive Summary

The U.S. Food and Drug Administration (FDA) has issued a set of regulations, collectively called 21 CFR Part 111 and commonly referred to as Part 11, that provide criteria for acceptance of electronic records and electronic signatures as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with the FDA's responsibility to promote and protect public health. Though electronic submissions are currently optional, the FDA is paving the way, with Part 11, for routine and eventually mandatory submission of clinical trial records electronically.

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