Part 11: Electronic Records; Electronic Signatures

In many industries today, the use of electronic records and signatures is becoming more common. This course explains the purpose of 21 CFR Part 11. Topics in this course include: Records Requirements, Records Security, Electronic Signatures, Signature Controls, and FDA Enforcement. After completing this course, learners will be able to recognize how to properly implement and use an electronic record or signature. FDA requirements for computerized systems that generate electronic records ensure that they and any electronic signatures applied to them are trustworthy, reliable, and traceable to the person(s), events, and actions taken to generate the records.

After this course learners will be able to identify the regulatory requirements for electronic records and electronic signatures. recognize fda expectations for compliance.