Part 11 Update by Christine Nelson of FDA

Presentation slides for “Update on FDA Part 11 Activities” given by Christine Nelson of FDA at the Biomedical Focus Meeting in July 2001.

The presentation lists the following draft guidances to be issued for comment:
Electronic copies for FDA
Archiving (Record Retention)
Audit trails
Time stamps

It also stresses that paper printouts are not an adequate substitute for electronic records.

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

Partners located in the US (CA, FL, MA, MN, TN) and Italy.