Biotage Extrahera LV-200 GLP Software Checklist

Significance of Topic

The proper installation and validation of Good Laboratory Practice (GLP) software is crucial for ensuring data integrity, regulatory compliance, and reliable operation of automated laboratory systems. In pharmaceutical, environmental, and chemical industries, adherence to GLP standards safeguards the reproducibility and traceability of analytical results, making software checklists an essential component of quality assurance.

Objectives and Overview of the Checklist

This document outlines a structured procedure to verify the successful installation, configuration, and functional testing of the Biotage Extrahera LV-200 GLP software. The main goals are:

• Confirm installation of the latest software version and valid license.
• Establish administrative user credentials and enforce password policies.
• Validate network connectivity and system login functionality.

Methodology and Instrumentation

The checklist organizes tasks into installation, configuration, and verification phases. Key steps include:

1. Software Installation
   • Deploy the GLP software on the target workstation.
   • Activate the supplied GLP license to enable full functionality.
2. Software Configuration
   • Create an administrator account with strong password requirements (8–40 characters, upper/lowercase, numeric).
   • Set password expiry to 120 days and confirm notification behavior.
3. Verification and Functional Testing
   • Test administrator login and logout sequences.
   • Ping the instrument’s LAN port to ensure network connectivity.

Main Results and Discussion

By following the checklist, users confirm that:

• The Biotage GLP software is installed with the correct version and validated license.
• Administrator credentials meet password policy and expiry requirements.
• System login and network interfaces function as expected.

Any deviations or errors encountered during these tests are recorded in the notes section, enabling targeted troubleshooting and corrective actions.

Benefits and Practical Applications

Implementing this GLP software validation checklist provides several advantages:

• Streamlines commissioning of the Extrahera LV-200 system for sample preparation workflows.
• Ensures compliance with regulatory audits by maintaining documented evidence of proper installation.
• Reduces downtime through early detection of configuration or network issues.

Future Trends and Potential Applications

As laboratory informatics evolve, future developments may include:

• Automated installation verification integrated into centralized Laboratory Information Management Systems (LIMS).
• Cloud-based monitoring of GLP software health and license status.
• Enhanced cybersecurity features, such as multi-factor authentication for administrative access.

Conclusion

The Biotage Extrahera LV-200 GLP Software Checklist provides a systematic approach to verify installation, configuration, and connectivity, ensuring the system meets stringent quality and regulatory requirements. Utilizing this checklist promotes consistent software deployment, aids in audit readiness, and enhances overall laboratory efficiency.

Použita instrumentace

The primary system covered by this checklist is the Biotage Extrahera LV-200 sample preparation platform equipped with GLP-compliant software.