Compliance-ready MS Chromeleon CDS: customer perspectives

Significance of the Topic

In pharmaceutical and contract analytical laboratories, managing multi-instrument workflows, maintaining compliance with regulations like 21 CFR Part 11, and ensuring data integrity are critical challenges. Centralizing data, methods, user management, and audit trails in a single chromatography data system (CDS) can enhance laboratory efficiency, reduce costs, and accelerate decision making while meeting stringent regulatory requirements.

Objectives and Study Overview

This case study examines customer experiences with Thermo Scientific Chromeleon Chromatography Data System (CDS) as a unified, compliance-ready enterprise solution. It highlights how various organizations—CMOs, CROs, QA/QC labs, and pharma companies—deploy Chromeleon CDS to centralize data, automate system suitability testing, secure eSignatures, and streamline chromatography and mass spectrometry (MS) workflows.

Methodology

Customers integrated Chromeleon CDS in multi-vendor environments, replacing disparate data systems. Key processes included:

• Centralized method and data storage with user privileges and version control
• Automated System Suitability Testing (SST) with intelligent run control to validate instrument performance
• Compliant electronic signatures and controlled report locking workflows
• Built-in eWorkflow procedures and customizable report templates to minimize manual steps
• Integration of chromatography and MS data acquisition, processing, and reporting

Instrumentation

Chromeleon CDS supports over 540 instrument modules from 20+ manufacturers, including:

• Thermo Scientific HPLC and GC systems
• Single- and triple-quadrupole mass spectrometers
• Orbitrap high-resolution accurate mass (HRAM) systems
• Secure XVault™ centralized database infrastructure

Main Results and Discussion

Across several sites, Chromeleon CDS delivered:

• Complete, easily filtered audit trails and version comparison tools for traceability
• 21 CFR Part 11-compliant eSignatures and locked electronic reports for structured review
• Automated SST to enable unattended operation and reduce failed runs
• Integrated report generation using the spreadsheet-based Report Designer, eliminating external data transcription
• Smart data processing tools (Cobra Wizard, SmartPeaks, MiniPlot thumbnails, Intact Mass Deconvolution) for rapid, consistent peak detection and review
• eWorkflow templates and sequence scheduling to ensure method compliance and unattended overnight operations

Organizations reported significant time savings (up to several hours per batch), improved data integrity, reduced manual errors, and simplified audit readiness.

Benefits and Practical Applications

By adopting Chromeleon CDS, laboratories achieve:

• Centralized control of methods, data, and user access for robust data governance
• Enhanced productivity through automated SST and unattended sequences
• Streamlined integration of chromatography and MS data in unified reports
• Reduced training and validation efforts owing to a single intuitive software platform
• Comprehensive compliance support for GMP, GxP, and regulatory audits

Future Trends and Opportunities

As data volumes grow and regulatory scrutiny intensifies, laboratories will increasingly adopt scalable, enterprise-level CDS solutions. Trends include:

• Further integration of high-resolution MS and multidimensional chromatography
• Advanced data analytics and machine-learning-driven peak detection
• Cloud-based deployment for global data sharing and real-time collaboration
• Expanded automation and closed-loop QC processes

Conclusion

Thermo Scientific Chromeleon CDS unifies chromatography and MS workflows in a single compliance-ready platform. Customer implementations demonstrate marked improvements in laboratory efficiency, data integrity, and audit readiness. By automating key processes and centralizing data, Chromeleon CDS helps pharmaceutical, CRO, and CMO laboratories meet regulatory demands while accelerating time to results.

References

• Sterling Pharma Solutions. Case Study 72207: Efficiency gains and compliance improvements with Chromeleon CDS.
• Broughton Laboratories. Case Study 80086: Client success through unique service and compliance.
• Regis Technologies. Case Study 70754: Efficiency gains in pharma/biopharma manufacturing.
• SAFC Madison, Sigma-Aldrich. Case Study 70797: Meeting 21 CFR Part 11 compliance.
• Symphogen. Case Study 73994: Productivity boost in antibody development using Chromeleon CDS.
• Bayer Pharma AG. Case Study 71783: Automated workflows for target mass identification.