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Industry Regulations : Guidelines and Tips Last Updated: Nov 17th, 2008 - 12:30:30


Industry Regulations : Guidelines and Tips
The FDA's regulation for the use of electronic records and signatures
If your organization is required to keep records or make reports to the United States Food and Drug Administration (FDA), you need to understand the Code of Federal Regulations, Title 21, Part 11 (21CFR11). This regulation provides the criteria by which the FDA will accept electronic records and signatures as equivalent to paper records and traditional handwritten signatures. 21CFR11 establishes clear requirements for ensuring that electronic records and signatures are trustworthy and reliable. Click here for the entire article.
Nov 12, 2003, 09:24


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