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