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所在平台: Udemy |
课程主页: https://www.udemy.com/course/auditing-gxp-computer-systems-for-regulatory-compliance/
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课程名称：审计GxP计算机系统以满足监管合规性 课程概述： 本课程将深入探讨审计GxP计算机系统的不同方面，重点介绍监管框架、EU Annex 11和CFR Part 11对GxP系统的要求。课程内容包括审计准备与问题分类，审计关键合规领域的结构化审计问题，风险管理、人员及供应商资格、验证流程、数据完整性与准确性检查、数据存储、打印输出、审计追踪和电子签名的管理。 课程目标： 1. 学习如何根据EU Annex 11和CFR Part 11对GxP计算机系统进行审计。 2. 了解如何准备和解读审计报告。 3. 提升计算机系统验证知识至GxP系统审计员级别。 审计GxP计算机系统不仅关注合规性，还确保数据完整性、安全性及可靠性。课程内容将探讨有效审计的关键领域，如风险管理、验证、安全控制和审计追踪等，评估系统文档是否完善、访问是否受控以及更改是否安全管理。遵循这些法规可帮助组织降低风险，维持监管批准，并确保患者安全。 最佳实践和审计报告分析将是课程的重要组成部分，使学员能够理解审计报告模板及相关文档的使用。
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.
