GxP Audit Trail Review | Stay Compliant with FDA & Annex 11
With regulatory scrutiny around audit trails on the rise – evidenced by a growing number of FDA Warning Letters and the upcoming revisions to EU Annex 11 – it is more important than ever to establish a compliant and effective audit trail review process.
Our latest guide introduces a practical, step-by-step framework designed to help you stay inspection-ready:
- Evaluate GxP-Relevant Systems: Start by assessing which systems are subject to GxP requirements and ensure they are capturing audit trail data completely and accurately. A clear understanding of your system landscape is key.
- Conduct Risk-Based Assessments: Regularly analyze critical data and system vulnerabilities to uncover potential compliance gaps. A structured risk assessment helps you prioritize what matters most.
- Enhance Systems and Processes: Replace manual workarounds and fragmented procedures with robust, validated solutions that provide reliable, audit-ready records.
Whether you’re refining your current processes or building a new strategy from the ground up, our flyer offers clear, actionable steps to help you build a strong foundation for audit trail compliance.
👉 Contact – GxP-CC for expert support.
