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21 CFR Part 11
Know the Required Components of 21 CFR Part 11
The 21 CFR Part 11 regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology. Although, at the time of publication of this web page, the use of electronic records as well as their submission to the FDA is voluntary, the agency makes extensive use of its web site to publish and update information regarding this and other important rules and regulations it maintains.
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