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
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.