SoftwareCPR 21 CFR Part 11 Reference Manual$

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions.

21 CFR Part 11 is a topic of current focus for FDA and industry.  This manual contains the most important FDA documents related to Part 11 as well as some key SoftwareCPR educational Aides as listed below:

This manual was updated on 10/24/2007 to reflect the Part 11 changes and redirection.

-FDA Electronic Records; Electronic Signatures Part 11 . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.