Biotage Extrahera - GLP Software Checklist

Importance of the Topic

Good laboratory practice (GLP) compliance is essential for ensuring data integrity, traceability and regulatory acceptance in analytical chemistry environments. A structured installation and validation process for GLP software reduces the risk of configuration errors and supports consistent quality assurance.

Objectives and Overview

The Biotage Extrahera GLP Software Checklist defines a step-by-step approach to install and validate the GLP software on the Extrahera system. The document guides field service engineers and customers through tasks from software installation and licensing to functional testing and record keeping.

Methodology and Instrumentation

A systematic sequence of activities ensures accurate setup and verification:

• Install the latest GLP software version
• Apply and activate the GLP license
• Create and verify a system administrator account with secure password settings
• Configure password expiry at 120 days and confirm reset notification
• Validate administrator login via remote viewer connection
• Test network port functionality by pinging the instrument IP address
• Perform hardware upgrade if serial number precedes 1200500329 according to service bulletin SB00146

Instrumentation
Biotage Extrahera automated solid phase extraction system equipped with GLP software and remote access capability.

Main Findings and Discussion

Completion of all checklist tasks verifies that the GLP software is installed correctly and meets operational requirements. The enforced password policy and expiry cycle enhance security. Network validation confirms reliable connectivity for data transfer and remote diagnostics. The hardware upgrade requirement ensures compatibility with the latest software features.

Benefits and Practical Applications

This structured installation and testing protocol provides:

• Regulatory compliance consistent with GLP guidelines
• Traceable documentation of installation steps and user credentials
• Reduced setup time and minimized configuration errors
• Enhanced system security through password policies
• Reliable network performance supporting remote monitoring

Future Trends and Potential Applications

Next generation GLP frameworks are expected to incorporate cloud based data management, integrated laboratory information management systems (LIMS), advanced cybersecurity measures and automated software updates. Enhanced remote access tools and predictive maintenance analytics will further optimize system uptime and data integrity.

Conclusion

The Biotage Extrahera GLP Software Checklist establishes a clear, verifiable process for software installation and validation. Adherence to these procedures ensures system readiness, data security and compliance with regulatory standards.

References

• Biotage Extrahera GLP Software Checklist, Literature Number UI430, Biotage 2020