Audit Trail Requirements under EU GMP Annex 11

Audit trails are a regulatory requirement across all major GMP frameworks, designed to ensure transparency and data integrity. The upcoming revision of EU GMP Annex 11 expands on these requirements, mandating that not only changes and deletions but also future data creation must be traceable.

According to experts, audit trails must capture all GMP-relevant interventions—specifically quality-critical data changes, operator actions, and acknowledged alarms or warnings that require user input. In contrast, system-generated notifications resolved without user action should be recorded in alarm or deviation lists, or in batch/examination reports.

Responsibility for defining audit trail relevance lies with both the supplier and the customer. While suppliers can identify critical system-level points, manufacturers must validate that all process-relevant parameters are appropriately covered and adjust configurations where necessary.

This collaborative approach ensures audit trails remain robust, compliant, and aligned with the unique needs of pharmaceutical manufacturing.

18-08-2025