White Paper
Tripwire and 21 CFR11: Ensuring Integrity and Trustworthiness of Electronic Clinical Data
The U.S. Food and Drug Administration (FDA) has issued a set of regulations, collectively called 21 CFR 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 21 CFR Part 11, for routine and eventually mandatory submission of clinical trial records electronically. The 21 CFR Part 11 provides in-depth guidelines and criteria for ensuring authenticity and integrity of digital records, and for documenting and validating authorized change processes to systems and software involved in the creation of digital records.
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