Biotage® Extrahera GLP Software

Importance of the Topic

Automated sample preparation is a cornerstone of modern analytical chemistry, ensuring reproducibility and throughput while minimizing manual error. In regulated environments such as pharmaceutical and environmental testing, compliance with Good Laboratory Practice (GLP) demands robust software controls, secure data handling, and complete audit trails. The integration of GLP features into high-throughput extraction platforms addresses growing demands for data integrity, traceability, and workflow efficiency.

Aims and Overview

This document introduces the Biotage® Extrahera™ GLP software package, designed to augment the existing Extrahera automated extraction system with features that align with GLP guidelines. Key objectives include:

• Defining user roles and access controls to match personnel training levels.
• Enhancing system security through password policies and session management.
• Enabling network integration with laboratory information management systems (LIMS).
• Implementing comprehensive audit trail functionality to capture every system change.

Methodology and Instrumentation Used

The Biotage Extrahera platform, available since 2015, supports a range of sample preparation techniques including Supported Liquid Extraction (SLE), Solid Phase Extraction (SPE), Phospholipid Depletion (PLD), and Protein Precipitation (PPT). The GLP software module adds layers of management, security, network communication, and audit capabilities. Instrumentation and features include:

• Extrahera hardware for automated liquid handling and extraction.
• GLP software with five distinct user roles: Routine User, Monitor User, QA/QC User, Power User, and System Administrator.
• Password-protected sessions with expiry, lockout thresholds, and optional USB port restrictions.
• Network connectivity for sample batch list import/export, email alerts, and remote viewing.
• Audit trail recording of method edits, consumable usage, system maintenance, and user actions.

Main Findings and Discussion

The GLP software enhances laboratory operations by segregating duties and permissions across defined roles, preventing unauthorized method modifications while preserving method integrity. Enhanced security measures guard against data tampering, and encrypted, non-editable PDF report export protects outputs. Network integration facilitates centralized data management and real-time error or completion notifications. The audit trail provides time-stamped, user-attributed records of all critical events, supporting swift and thorough regulatory audits.

Benefits and Practical Applications

The combined Extrahera and GLP software solution delivers:

• Improved compliance with GLP requirements through robust user management and audit capabilities.
• Reduced risk of data loss or unauthorized modifications via secure passwords and session controls.
• Streamlined workflows by automating sample list handling and remote monitoring.
• Enhanced transparency for quality assurance and regulatory inspections.
• Flexibility to add GLP functionality to existing Extrahera units with software upgrades.

Future Trends and Applications

Looking forward, potential developments include:

• Integration of 21 CFR Part 11 compliance features for electronic records and signatures.
• Unified user authentication across multiple devices to streamline operations in multi-instrument laboratories.
• Advanced data analytics and machine learning modules for predictive maintenance and process optimization.
• Cloud-based data storage and secure remote collaboration features.

Conclusion

The Biotage Extrahera GLP software package significantly bolsters the capabilities of the automated extraction system by embedding essential GLP controls. Laboratories gain enhanced data security, traceability, and workflow efficiency, positioning the Extrahera platform as a powerful tool for regulated and high-throughput analytical environments.