Part 11: Electronic Records and Signatures -- Changes in Enforcement Policy

Since the inception of Part11, FDA has issued changes to the enforcement policy for electronic records and signatures. This course describes how to implement the new changes of Part 11 enforcement. Topics in this course include: Key Changes, FDA Enforcement, and Unaffected Provisions. After completing this course, learners will be able to recognize FDA expectations for compliance with all applicable predicate rules.

After this course learners will be able to recognize fda expectations for compliance with all applicable predicate rules. identify how the agency plans to interpret and enforce part 11 with regard to the use of electronic records and electronic signatures.