Today, FDA issued a new Part 11 guidance draft that reduces the scope and burden of Part 11 significantly. It essentially suspends enforcement on legacy systems existing prior to the rule’s effective date in 1997 and eliminates: enforcement related to audit trails, electronic copies, and maintenance of electronic records by focusing on meeting the intent...Read More
“Being Agile & Compliant”
2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019
Come meet John F. Murray, Jr. at the course!
Contact us using this form between 1/19/19 and 1/23/19 to get additional discount!