Ask the Expert

Where to find resources on 21CFR11

Where can I find more information regarding The Code of Federal Regulations, Title 21, Part 11 (21CFR11). This regulation talks about digital signitures. I need to know if the USB token (eToken) I have developed complies with these standards. Any suggestions?

    Requires Free Membership to View

21CFR11 is an FDA regulation dealing with data handling. It handles "criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper."

Here are some sources on 21CFR11:
Information on 21CFR11
Compliance with 21CFR11

For more information on this topic, visit these other resources: Search Results: 21CFR11
Best Web Links: Law, Public Policy and Standards

This was first published in November 2002

There are Comments. Add yours.

TIP: Want to include a code block in your comment? Use <pre> or <code> tags around the desired text. Ex: <code>insert code</code>

REGISTER or login:

Forgot Password?
By submitting you agree to receive email from TechTarget and its partners. If you reside outside of the United States, you consent to having your personal data transferred to and processed in the United States. Privacy
Sort by: OldestNewest

Forgot Password?

No problem! Submit your e-mail address below. We'll send you an email containing your password.

Your password has been sent to: