Using Audit Trails To Support Part 11 Data Integrity Compliance

  • Instructor : Carolyn Troiano
  • Level : Intermediate
  • Study time : 102 minutes
  • Course ID: TF3643
  • Included in Subscription Pack
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ABOUT THE COURSE

Are your audit trails capturing the right details — consistently and completely?
Can you prove the integrity of every record from creation to disposition?
Would your system’s data history survive an FDA inspection without gaps or excuses?


This training takes you inside the audit trail expectations behind 21 CFR Part 11 — showing what’s required, what goes wrong, and how to avoid costly validation and compliance failures.


WHAT WILL YOU GAIN
  • Clarity on how audit trails support data integrity and meet Part 11 standards
  • Tools to assess, document, and justify audit trail use in risk-based validation
  • Real-world tactics for legacy systems, procedural controls, and FDA audit prep


WHY TAKE THIS COURSE
  • Audit trail issues are among the top FDA 483 and Warning Letter triggers
  • Learn what to implement — not just why it matters — for real inspection readiness
  • Designed for modern systems *and* legacy tools still in active use


KEY AREAS COVERED
  • Understanding audit trails in the context of Part 11 and data integrity regulations
  • Using SDLC and CSV to justify, implement, and validate audit trail capability
  • How to handle systems without technical controls using procedural alternatives
  • What makes an audit trail compliant — from record changes to user justification
  • Best practices for maintaining validated state, inspection prep, and documentation
  • Risk-based validation rationale using system size, GAMP 5 category, and criticality

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano is a leading authority on computer system validation and Part 11 compliance, with 30+ years supporting top life sciences firms and shaping industry best practices. She’s guided companies through high-stakes audits, designed system validation programs since the 1980s, and helped translate FDA expectations into practical execution. Her insights are trusted, proven, and regulatory-aligned.

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