Audit Trail Requirements Under EU GMP Annex 11: Key Insights from Industry and Inspectors

The draft revision of EU GMP Annex 11 significantly expands on audit trail expectations, emphasizing transparency in data lifecycle management. Six experts from regulatory bodies and the pharmaceutical industry addressed key questions concerning current requirements.

Question 1: Inspectors require audit trails to capture who made a change, what was changed, when, and how. This includes the original and modified values and the rationale for any change or deletion. These minimum criteria are specified in EU GMP Annex 11 and Chapter 4. The German Aide Memoire ‘Supervision of Computerised Systems’ provides further guidance for inspections.

Question 2: Audit trails must be printable. Annex 11, Section 8 mandates the ability to generate clear hard copies of electronic records. For batch release data, printouts must show if any changes occurred after initial entry.

These requirements help ensure data integrity and regulatory compliance throughout the product lifecycle.

16-07-2025