Auditing GxP Computer Systems for Regulatory Compliance

Auditing GxP Computer Systems for Regulatory Compliance in Accordance with EU Annex 11 and CFR Part 11

What you'll learn
Auditing GxP Computer Systems: Compliance & Best Practices
GxP Computer System Auditing: Ensuring Compliance & Data Integrity
Auditing GxP Computer Systems for Regulatory Compliance
Mastering GxP Computer System Audits: A Practical Guide

Requirements
Basic experience with computer system validation

Description
Course Scope: Auditing GxP Computer SystemsIntroduction to Regulatory FrameworksOverview of EU Annex 11 and CFR Part 11 requirements for GxP systems.Audit Preparation & Question CategorizationStructuring audit questions based on key compliance areas.Auditing Key Compliance AreasRisk Management, Personnel, and Supplier QualificationValidation Processes, Data Integrity, and Accuracy ChecksData Storage, Printouts, Audit Trails, and Electronic SignaturesChange & Configuration Management, Security, and Incident ManagementPeriodic Evaluations, Batch Release, and Business ContinuitySystem Documentation, Archiving, and Record RetentionAudit Execution & ReportingBest practices for conducting audits.Analyzing and interpreting audit reports.Understanding audit report templates and documentation.The goal of the courseUnderstand how to perform an audit of GxP computer systems based on EU Annex 11 and CFR Part 11.Learn how to prepare and interpret an audit report.Upgrade your Computer System Validation knowledge to the GxP System Auditor level.Auditing GxP Computer Systems: EU Annex 11 & CFR Part 11Auditing GxP computer systems ensures compliance with regulatory requirements, safeguarding data integrity, security, and reliability. EU Annex 11 (European Union) and CFR Part 11 (U.S. FDA) set the standards for electronic records, electronic signatures, and computerized system validation in regulated industries.An effective audit focuses on key areas such as risk management, validation, data integrity, security controls, audit trails, and electronic signatures. It assesses whether systems are properly documented, access is controlled, and changes are managed securely. Compliance with these regulations helps organizations mitigate risks, maintain regulatory approval, and ensure patient safety.

Who this course is for
computer system validation specialist
internal auditor
external auditor
system auditor
auditor
computer system validation specialist
GxP specialist