MassHunter Data Acquisition for 6400 Series and Ultivo LC/TQ Compliance (with ECM) Mode - Quick Start Guide

Importance of the Topic

In regulated laboratories, maintaining data integrity and meeting electronic record requirements is critical. Compliance with regulations such as 21 CFR Part 11 ensures that electronic data and signatures are treated with the same rigor as paper records. Implementing a secure, auditable acquisition system reduces risk, supports quality management, and simplifies regulatory audits.

Goals and Overview of the Guide

This Quick Start Guide presents a step-by-step approach to install, configure and operate Agilent MassHunter Data Acquisition in Compliance (with ECM) mode. It covers the 6400 Series Triple Quadrupole LC/MS (B.08.01 and later) and Ultivo LC/TQ (1.1 and later), integrating with Agilent OpenLab Enterprise Content Manager to enforce traceability, access control and data security.

Instrumentation

• Agilent 6400 Series Triple Quadrupole LC/MS
• Agilent Ultivo LC/TQ
• MassHunter Data Acquisition software (B.08.01+, 10.0+)
• Agilent OpenLab Enterprise Content Manager (ECM) server and client

Methodology

The setup workflow comprises four main phases:

1. Install and configure the OpenLab ECM server and database account.
2. Install the ECM client components on each workstation and add the server to trusted sites.
3. Enable Compliance (with ECM) mode via the System Configuration Utility and define storage paths.
4. Create and assign users, groups and the predefined Data Acquisition roles (Acq_Operator, Acq_Chemist, Acq_Manager) on the ECM server.

Subsequent admin tasks include assigning instrument-specific access, clearing local ECM cache, viewing audit trails and importing acquisition methods into ECM.

Main Results and Discussion

The Compliance (with ECM) mode introduces:

• Role-based access controls and enforced login via ECM credentials.
• Detailed audit trails and eSignatures through ECM integration.
• Hash signatures and automatic checksum validation to detect tampering.
• Automatic session lockouts and restricted software functions based on role.
• Centralized storage of methods, worklists and data with versioning.

Compared to standard mode, the compliance setup prevents on-the-fly editing of methods during acquisition, enforces save actions before runs, and uses a four-level ECM storage path instead of local folders.

Benefits and Practical Applications

Laboratories using Compliance mode gain:

• Regulatory readiness with built-in support for 21 CFR Part 11.
• Secure, centralized management of acquisition methods and data.
• Enhanced data integrity via checksum and hash verification.
• Controlled user privileges and clear audit trails.
• Reduced risk of unauthorized changes or data loss.

Future Trends and Potential Applications

Emerging developments may include:

• Cloud-based ECM deployments for global collaboration.
• AI-driven analytics for automated compliance monitoring.
• Integration with LIMS and laboratory workflow platforms.
• Mobile and remote e-signature capabilities.
• Predictive maintenance and data integrity dashboards.

Conclusion

Implementing MassHunter Data Acquisition in Compliance (with ECM) mode delivers a robust, auditable platform for LC/TQ analyses. By enforcing role-based controls, securing data with checksums and maintaining detailed audit trails, laboratories improve regulatory compliance, data integrity and operational efficiency.

References

• FDA 21 CFR Part 11 Guidance for Industry.
• Agilent OpenLab Enterprise Content Manager Installation Guide.
• Agilent MassHunter Data Acquisition Online Help.