Biotage Extrahera GLP Software - User Manual

Significance of the Topic

Analytical laboratories operating under Good Laboratory Practice (GLP) require robust software to manage automated sample preparation with traceability, data integrity, and regulatory compliance. The Biotage Extrahera GLP Software extends automated SPE/SLE workflows by enforcing user access controls, method locking, audit trails, and secure reporting.

Objectives and Article Overview

This document presents the core features, configuration steps, and operational procedures for the optional Biotage Extrahera GLP Software license on LV-200 systems. It covers user account management, method creation and locking, network integration, sample batch worklists, dynamic reporting, and backup/restoration workflows.

Methodology and Instrumentation

The software interfaces with the Biotage Extrahera LV-200 automated extractor. Key functionalities include sample identification via touch screen or imported SBWL templates, clog detection during SPE/SLE/Filtration+ steps, dynamic report assembly, and secure PDF/text export. Network connectivity enables email notifications, remote web-based run monitoring, and centralized storage on SMB/CIFS shares or USB devices. Scheduled and manual backups preserve all methods, consumable definitions, run reports, and audit trails.

Main Results and Discussion

User roles range from system administrator to monitor, each with defined permissions for method editing, data administration, and system settings. The software logs every action in multiple audit trails—operational, method, data administration, maintenance, system administration, master and service. Dynamic reporting allows inclusion or exclusion of individual run details and end-of-run comments. Clog detection sensitivity and automatic pressure application are configurable per method. Remote Viewer provides real-time status updates and report downloads in locked PDF format.

Benefits and Practical Applications

By enforcing controlled method edits, password-protected locking, and detailed audit logs, the GLP software ensures full compliance with regulatory requirements. Email alerts for run pauses, failures, and completions improve operator oversight. Automated exports and network integration facilitate QA/QC documentation, secure archiving, and efficient data retrieval.

Future Trends and Potential Uses

Future enhancements may include deeper LIMS and laboratory information system integration, expanded consumable compatibility for clog detection, AI-assisted clog prediction and pressure optimization, and cloud-based analytics leveraging accumulated operational data for predictive maintenance and workflow optimization.

Conclusion

The Biotage Extrahera GLP Software package enhances the automated extraction platform with essential features for GLP compliance, secure user management, comprehensive audit trails, and flexible reporting. It supports robust, traceable sample preparation workflows in analytical and QA/QC laboratories.

References

• Biotage Extrahera GLP Software User Manual, Biotage AB, 2021