Part 11: Electronic Records and Signatures -- Application

In many organizations today, electronic records and electronic signatures are becoming more common. This course identifies how to implement Part 11 and what it means in terms of FDA’s enforcement policy for 21 CFR Part 11, Electronic Records; Electronic Signatures. Topics in this course include: Meeting Expectations, Records, Security, Electronic Signatures, System Documentation, and Audit Trails. After completing this course, learners will be able to recognize how to apply Part 11 regulations to your company’s systems and records in accordance with FDA’s expectations.

After this course learners will be able to recognize how to apply part 11 regulations to your company’s systems and records in accordance with fda’s expectations. identify what records are considered part 11 records. identify how system documentation is controlled.