FDA Responds to Petition to Withdraw Part 11

In September of 2004 an Industry Coalition on Part 11 submitted a citizen’s petition to formally request that FDA withdraw the Part 11 regulation. FDA responded Mar 15, 2005 saying they have been unable to reach a decision. The letter is at the link provided.

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.