Biotage® Extrahera GLP Software

Significance of the topic

Automated sample preparation plays a pivotal role in ensuring reproducibility, throughput and regulatory compliance in analytical chemistry laboratories. The integration of Good Laboratory Practice (GLP) features into automated platforms like the Biotage Extrahera enables secure data handling, traceable workflows and streamlined audit processes for pharmaceutical, forensic and environmental testing.

Objectives and overview of the application note

This document introduces the GLP software extension for the Biotage Extrahera system. It outlines the key software features—user management, data security, network integration and audit trail functionality—designed to support GLP-compliant sample preparation using Supported Liquid Extraction (SLE), Solid Phase Extraction (SPE), Phospholipid Depletion (PLD) and Protein Precipitation (PPT) protocols.

Methodology and workflow

The Extrahera GLP software adds structured control layers to the existing Extrahera automation. Laboratories import sample batch work lists, execute preparations under defined user roles, and generate reports that are automatically timestamped and digitally signed. The audit trail captures every system event, method change and consumable use, ensuring full traceability.

Used instrumentation

• Biotage Extrahera automated sample preparation workstation with pipetting head and reagent reservoirs
• GLP software package featuring five predefined user roles: Routine User, Monitor User, QA/QC User, Power User and System Administrator
• Support for SLE, SPE, PLD and PPT methods in 48×3 mL cartridge or plate formats
• LAN and LIMS connectivity for sample list import/export, email notifications and remote monitoring

Main results and discussion

Key enhancements introduced by the GLP software include:

• Manage: Five-tiered user role system with password policies and session timeouts to restrict access according to training level
• Secure: Encrypted, integrity-checked passwords; USB port restrictions; export of noneditable, password-protected PDF reports or LIMS-compatible TXT files
• Network: Full integration with LAN/LIMS for backup/restore, remote viewing of runs and automated email alerts on errors or run completions
• Audit: Comprehensive, time-stamped audit trail covering method edits, consumable usage, maintenance and service events, all requiring user comments for changes

Benefits and practical applications

By combining automated sample prep with GLP compliance features, the Extrahera GLP software accelerates throughput while maintaining rigorous data integrity. Laboratories benefit from reduced manual intervention, simplified audit readiness and improved cross-site standardization. Remote monitoring and standardized report formats further facilitate collaborative workflows and regulatory submissions.

Future trends and possibilities

Potential advancements include 21 CFR Part 11–compliant data modules, cloud-based audit trail archiving, AI-driven method optimization and expanded LIMS interoperability. Integration of barcode and RFID tracking, as well as mobile app alerts, may further enhance sample traceability and operator productivity.

Conclusion

The addition of GLP software to the Biotage Extrahera platform transforms a high-throughput sample preparation system into a fully compliant GLP solution. Enhanced user control, data security, network connectivity and audit functionality address the evolving needs of regulated laboratories, ensuring both efficiency and traceability.