$Part 11 Warning Letter Excerpts in one pdf file$

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

The attached pdf file contains all Part 11 related warning letter excerpts included on this site as of the date above.  This file is updated periodically, but for the most recent warning letters between these updates, do text searches on the website.  Since not all Part 11 related warning letters actually mention Part 11, we search on security and electronic record as well.  Link . . .

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.