Compliance-ready MS Chromeleon CDS: customer perspectives

Importance of the Topic

Chromatography and mass spectrometry workflows in pharmaceutical, contract testing, research, and manufacturing laboratories demand efficient data management, regulatory compliance, and rapid decision-making.
Integrating multiple instruments and software platforms into a single compliance-ready system reduces manual steps, ensures data integrity, and accelerates analytical throughput.

Objectives and Overview

This collection of customer case studies highlights Thermo Scientific Chromeleon Chromatography Data System (CDS) implementations resulting in:

• Centralized methods and data storage across multi-vendor instruments
• Full compliance with GxP and 21 CFR Part 11 regulations
• Automated system suitability testing and quality control workflows
• Seamless integration of chromatography and mass spectrometry

Methodology and Used Instrumentation

Chromeleon CDS is deployed as a client/server enterprise solution featuring:

• Multi-vendor support for over 540 instrument modules (HPLC, GC, mono/tri-quadrupole and Orbitrap MS)
• Secure centralized data vault (XVault™) with role-based access controls (160+ permission levels)
• Comprehensive audit trails, version control, and compliant electronic signatures
• Automated System Suitability Testing covering injection repeatability, peak shape, retention, concentration and more
• Guided eWorkflow™ procedures and intelligent run control for error-free sequence setup
• Advanced processing tools (Cobra™ Wizard, SmartPeaks™ Integration Assistant, intact mass deconvolution)
• Enhanced data review with MiniPlot™ thumbnails and SmartLink panes
• Flexible, spreadsheet-based Report Designer for consolidated reporting and locked templates

Main Results and Discussion

Customer feedback and measured outcomes include:

• Robust audit trails and version comparison ensuring full traceability of analyst actions
• 21 CFR Part 11 compliant eSignatures and locked electronic reports to prevent unauthorized changes
• Automated SST enabling unattended runs, improving productivity by utilizing off-shift hours
• Centralized data resourcing enhancing backup, integrity, and global access
• Unified chromatography-MS workflows reducing software switching and training time
• Automated data processing and reporting tools eliminating manual transcription and saving hours per run
• Intuitive interface minimizing learning curves and increasing user adoption

Benefits and Practical Applications

Key advantages realized by organizations:

• Faster time to results through streamlined, automated workflows
• Strengthened data integrity via secure storage, controlled access, and comprehensive audit trails
• Regulatory readiness with built-in compliance features supporting QA/QC and GMP environments
• Scalability for multi-site deployment and consistent global operations
• Significant labor savings by automating SST, sequence creation, and report generation

Future Trends and Opportunities

Emerging developments likely to shape analytical labs include:

• AI-driven peak detection, deconvolution, and anomaly identification for enhanced data accuracy
• Cloud-based CDS deployment for remote access, real-time collaboration, and advanced analytics
• Expanded eWorkflow templates and integration with electronic laboratory notebooks and LIMS
• Advanced visualization tools and machine learning to optimize method performance
• Mobile interfaces for on-the-go data review and decision support

Conclusion

Thermo Scientific Chromeleon CDS offers a unified, compliance-ready platform that centralizes chromatography and mass spectrometry workflows. By integrating instrument control, data management, and reporting into a single solution, it reduces manual effort, enhances data integrity, and accelerates analytical operations. Its scalable architecture and comprehensive feature set address current and evolving regulatory and productivity needs in pharmaceutical research, development, and contract manufacturing.

References

• Case Study 72207, Sterling Pharma Solutions: Efficiency and compliance gains
• Case Study 80086, Broughton Laboratories: GMP data integrity and audit readiness
• Case Study 70754, Regis Technologies: Multi-lab 21 CFR environment validation
• Case Study 70797, SAFC Madison: Centralized audit trails and eSignatures
• Case Study 73994, Symphogen: High-throughput intact protein analysis
• Case Study 71783, Bayer Pharma AG: Automated target mass detection workflow