ValGenesis VLMS Compliance Assessment - FDA 21 CFR Part II

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.