Audit Trail Generation and Review
In this webinar 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. 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.
Duration:
90 Minutes
Product Id:
502629
Access:
6 months
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Overview:
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Why should you Attend:
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
- What records need to have an Audit Trail
- When does Audit Trail begin
- What clock should be used for the timestamp
- How is Audit Trail versioned
- How is Audit Trail stored
- What if my system does not have automated Audit Trail
- What about "hybrid" systems
- How to review audit trails
- Risk Based Approach
- Best Practices
- Audit Trail and Data Integrity
Who Will Benefit:
- GxP
- Consultants
- Quality VPs
- IT VPs
- FDA Investigators
- Other Regulatory Agency Investigators
