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Medical Devices, Pharmaceuticals

Part 11 Electronic Records and Signatures Application

About the Course

In many organizations today, electronic records and electronic signatures are becoming more common. This online 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 eLearning course include: Meeting Expectations, Records, Security, Electronic Signatures, System Documentation, and Audit Trails. After completing this compliance 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.