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Based on the increased use of computer systems in the pharmaceutical industry,
the United States Food and Drug Administration (US FDA) issued the 21 CFR Part 11
regulations in March of 1997. This regulation provides the criteria for acceptance by
the FDA, under certain circumstances, of electronic records, electronic signatures,
and handwritten signatures executed to electronic records as equivalent to paper
records and handwritten signatures executed on paper.
The intent of the 21 CFR Part 11 rule is to define controls for computer systems and
to encourage the greatest possible use of electronic technology while still allowing
the FDA to follow its mandate to protect public health. This regulation outlines the
controls necessary for those that choose to utilize electronic records and electronic
signatures. It establishes criteria for the creation and management of electronic
records and electronic signatures. This paper contains information about the FDA
ruling as well as how ValGenesis VLMS (Validation Lifecycle Management Systems)
meets 21 CFR Part 11 requirements.
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