Agilent MassHunter Data Acquisition User Management and Audit Trail - Quick Start Guide

Importance of the topic

User Management and Audit Trail is critical for regulated laboratories to maintain electronic data integrity, ensure compliance with FDA 21 CFR Part 11, and guarantee that electronic records and signatures are reliable and secure.

Aims and overview of the guide

This Quick Start Guide outlines the steps to install, configure, and operate the User Management and Audit Trail features of Agilent MassHunter Data Acquisition software for LC/MS systems. It addresses both system administrator and user workflows to enable controlled access, track changes, and protect data files from unauthorized modifications.

Methodology and instrumentation

• Software: Agilent MassHunter Data Acquisition for Triple Quad LC/MS (B.08.01+, B.09.00/10.0) and TOF/Q-TOF LC/MS (B.08.00+, B.09.00/10.0).
• System Configuration utility: to enable or disable User Management and Audit Trail mode.
• Windows Local Users and Groups: for role definition (Acq_Manager, Acq_Chemist, Acq_Operator, Acq_No_Privileges).
• Method Audit Trail Viewer: a tool to review version history, edit reasons, and user actions for method files.
• Check Batch Files tool (in Compliance software): to verify data file integrity via hash signatures.

Main results and discussion

• Enabling the feature establishes predefined roles with specific privileges for instrument control, method editing, and study management.
• File integrity is secured by generating SHA-based hash signatures for each data file, detectable via compliance tools.
• Audit trails record user actions, timestamps, and reasons for method modifications, ensuring full traceability of analytical methods.
• Session locking and password-protected login prevent unauthorized access during unattended operation.

Benefits and practical applications

• Ensures compliance with FDA 21 CFR Part 11 by combining electronic signatures, audit trails, and role-based access.
• Enhances data security and integrity through hash checks and immutable audit records.
• Improves laboratory efficiency by defining clear user roles, reducing risk of configuration errors.
• Facilitates regulatory audits by providing accessible logs of all critical operations.

Future trends and opportunities

Advancements may include deeper integration with Electronic Lab Notebooks (ELN) and Laboratory Information Management Systems (LIMS), automated anomaly detection in audit trails using machine learning, and support for cloud-based compliance architectures to streamline multi-site data management.

Conclusion

The MassHunter User Management and Audit Trail module provides a robust framework for enforcing data integrity, securing instrument operations, and meeting regulatory requirements. Its modular roles, audit logging, and file verification tools form the backbone of compliant analytical workflows in modern laboratories.

Reference

• US Food and Drug Administration. 21 CFR Part 11: Electronic Records; Electronic Signatures. Guidance for Industry. 2003.