Why are audit trails important for electronic GLP records?

• A. They help verify changes and access; required for electronic records
• B. They are optional for most studies
• C. They apply only to paper records
• D. They are used to replace data validation

Answer: (A)

Audit trails capture a secure, time-stamped history of all actions on an electronic GLP record—who accessed it, what changes were made, when they were made, and from where. This creates traceability and accountability, so you can verify exactly what was entered or altered and by whom. Such traceability is essential for data integrity in GLP studies and is a regulatory expectation for electronic records, helping inspectors confirm that data has not been retroactively changed and that changes are legitimate and authorized. Audit trails support data validation by showing the data’s provenance and lifecycle, but they do not replace the need for validating that data are accurate and reliable in the first place. They apply to electronic records, not to paper records, and they are not optional in compliant systems.