Audit Trail [Generation] and Review 2019

Overview: These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. Why should you Attend: Additionally, attendees will learn how to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis. Areas Covered in the Session: What is an Audit Trail 21 CFR 11 / Annex 11 requirements for Audit Trails Why Audit Trails What are Audit Trail Features What are Audit Trail Contents