As health and life sciences industries continue to shift from paper to digital, CFR 21 Part 11, a regulation issued by the U.S. Food and Drug Administration (FDA), has become a cornerstone of compliant electronic recordkeeping. It defines how organizations must manage electronic records and signatures to ensure they are as trustworthy, reliable, and legally valid as their paper counterparts.
Compliance is essential for any organization using electronic systems in FDA-regulated environments, such as:
In this webinar, we’ll break down the essentials of CFR 21 Part 11, including:
Michael Henry
VP, Growth Strategy | Drummond
Michael Zgourovski
Risk Assessor | Drummond
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