Audit Trail Generation and Review

Live Webinar

  • 90 minutes

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.

Join this session by expert speaker Angela Bazigos, where she will 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.

Session Highlights:

  • What is an Audit Trail

  • 21 CFR 11 / Annex 11 requirements for Audit Trails

  • Why Audit Trails

  • What are Audit Trail Features

  • What is 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

  • Risk-Based Approach

  • Best Practices

  • Audit Trail and Data Integrity

Why You Should 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

Who Should Attend:

  • Quality Managers

  • Quality Engineers

  • Small business owners

  • GxP

  • Consultants

  • Quality VPs

  • IT VPs

  • FDA investigators

  • Other regulatory agency investigators

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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