Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. 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.One of the requirements for such compliance is the generation and review of audit trails. Thousands of audit trail records can be generated on a daily basis.Learning ObjectivesWhat is an Audit Trail21 CFR 11 / Annex 11 requirements for Audit TrailsWhy Audit TrailsWhat are Audit Trail FeaturesWhat are Audit Trail ContentsWhat records need to have an Audit TrailWhen does Audit Trail beginWhat clock should be used for the timestampHow is Audit Trail versionedHow is Audit Trail storedWhat if my system does not have an automated Audit TrailWhat about “hybrid” systemsHow to review audit trailso Risk-Based Approacho Best PracticesAudit Trail and Data IntegrityCourse Level : Basic / IntermediateWho Should AttendQuality ManagersQuality EngineersSmall business ownersGxPConsultantsQuality VPsIT VPsFDA investigatorsOther regulatory agency investigatorsWhy Should You AttendThis webinar will demystify audit trails and describe the benefits of an 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.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.
Single
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. 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.
One of the requirements for such compliance is the generation and review of audit trails. Thousands of audit trail records can be generated on a daily basis.
Learning Objectives
- 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 an automated Audit Trail
- What about “hybrid” systems
- How to review audit trails
o Risk-Based Approach
o Best Practices - Audit Trail and Data Integrity
Course Level : Basic / Intermediate
Who Should Attend
- Quality Managers
- Quality Engineers
- Small business owners
- GxP
- Consultants
- Quality VPs
- IT VPs
- FDA investigators
- Other regulatory agency investigators
Why Should You Attend
This webinar will demystify audit trails and describe the benefits of an 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.
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.
