Empower Software Audit Trails and Logs: A guide to the different locations of audit trails in Empower and what information they provide to reviewers

Significance of the Topic

Audit trails and logs in laboratory software are fundamental safeguards for data integrity and regulatory compliance with electronic record requirements (21 CFR Part 11, GMP, GLP, GCP). Absence or misconfiguration of these logs can compromise product quality and invite regulatory censure.

Study Objectives and Overview

This white paper examines the various types of audit trails and logs in Empower Software, detailing their locations, contents, and utility for reviewers in regulated laboratories. It highlights best practices for enabling, configuring, and reviewing these records to ensure complete and consistent traceability.

Methodology

The study categorizes audit features into system audit trails, project audit trails, acquisition logs, method histories, sample histories, and message logs. It reviews regulatory guidance on time stamping, access controls, and audit trail configurations, and demonstrates tools for comparing versions and enforcing risk-based review protocols.

Instrumentation Used

• Empower 3 Software with Oracle database backend
• Waters ACQUITY UPLC systems and detectors
• NuGenesis Laboratory Management System (LMS) for automated archiving
• Instrumentation-specific consoles with built-in error logs

Main Results and Discussion

Empower’s system audit trails capture global configuration actions, while project audit trails record data-related events (creation, modification, deletion) with operator-independent, time-stamped entries and reasons for change. Acquisition and injection logs permanently link run-time instrument settings to raw data. Method and sample histories maintain immutable version chains. The Result Audit Viewer consolidates multiple audit sources for streamlined review. Time synchronization, automated backups, and archive mechanisms ensure availability and integrity of audit records.

Benefits and Practical Applications

These comprehensive audit capabilities enable laboratories to detect unauthorized changes, support regulatory inspections, and facilitate risk-based data review workflows. The ability to compare method versions, filter audit entries, and electronically sign review outcomes improves operational efficiency and data transparency.

Future Trends and Applications

Emerging directions include automated audit trail analysis with machine learning, blockchain-backed immutable logs, cloud-based synchronized time services, advanced dashboarding for anomaly detection, and deeper integration with digital signature frameworks to further strengthen data integrity practices.

Conclusion

Empower Software’s robust audit trail framework delivers secure, unalterable records essential for regulatory compliance and data integrity. Implementing structured review procedures and leveraging integrated audit tools ensures traceability and supports high-quality analytical results.

Reference

1. FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures
2. OECD Series Number 17: Application of GLP Principles to Computerized Systems (2016)
3. WHO Technical Report Series 996 Annex 05: Computerized Systems in GLP
4. EU GMP Annex 11: Computerized Systems
5. PIC/S GMP Guide Annex 11: Computerized Systems
6. FDA Guidance on Records and Reports (current Good Manufacturing Practices)
7. FDA Title 21 CFR Part 211 GMP for Finished Pharmaceuticals