What is the purpose of an audit trail in GLP data systems?

• A. They record who accessed or changed data and when, supporting traceability
• B. They replace backups
• C. They guarantee data is encrypted
• D. They track budget

Answer: (A)

Audit trails capture who accessed or changed data and when, providing traceability and accountability. In GLP data systems, knowing exactly who did what, when, and what the data looked like before and after changes is essential for data integrity and regulatory compliance. This ability to reconstruct events helps detect unauthorized access or edits and supports audits and inspections by showing a complete history of data activity.

Backups are for preserving copies of data for recovery after loss, not for recording data usage or changes. Encryption protects data confidentiality, not the activity history. Tracking budgets is unrelated to data integrity and traceability in GLP systems.