Thermo Scientific Enterprise Software Solutions for Compliance and Data Integrity

Importance of the topic

In highly regulated industries such as pharmaceuticals and biotech, ensuring data integrity and compliance with regulatory standards is critical to protect public safety and maintain consumer confidence. Chromatography Data Systems (CDS) must provide robust technical controls alongside procedural practices to safeguard the validity of analytical results.

Objectives and overview

This document presents Thermo Fisher Scientific’s Enterprise Chromatography Solutions, emphasizing compliance with data integrity guidelines and 21 CFR Part 11. Key focus areas include:

• Implementing a single CDS package to manage electronic records and signatures.
• Preventing and detecting data integrity issues through audit trails.
• Leveraging cloud deployments for cost savings and enhanced connectivity.
• Demonstrating real-world benefits via case studies and resource materials.

Methodology and instrumentation

Thermo Fisher’s Chromeleon CDS integrates the following technical controls and features:

• Secure access control and electronic signatures compliant with 21 CFR Part 11.
• Comprehensive audit trails capturing who, what, when and why changes occur.
• Centralized data storage enabling multi-laboratory networks and shared workflows.
• Cloud-based deployment options offering scalability, remote access, and streamlined maintenance.
• Compatibility with liquid, gas and ion chromatography systems (LC, GC, IC) from multiple vendors.

Main results and discussion

Extensive evaluation has shown that Chromeleon CDS:

• Satisfies all 19 requirements of 21 CFR Part 11, reducing validation effort.
• Provides built-in prevention (e.g. disabling injection deletions) and detection (audit trail review) controls.
• Enables secure, long-term retention and reconstruction of historical data.
• Delivers improved efficiency and compliance in case studies: Sterling Pharma Solutions saved time and costs, and Millipore Sigma achieved seamless networked instrument control.

Benefits and practical application

By adopting Chromeleon CDS, laboratories gain:

• Streamlined regulatory compliance and minimized audit risk.
• Enhanced data security and traceability across the analysis lifecycle.
• Standardized workflows with eWorkflows and report templates for ‘right-first-time’ results.
• Cost savings through centralized management and cloud-based infrastructure.
• Flexibility to control diverse instruments from a single platform.

Future trends and application possibilities

Emerging developments in laboratory informatics include:

• Deeper integration of CDS with LIMS and SDMS for unified data ecosystems.
• Expansion of cloud-native solutions and hybrid deployments.
• Advanced analytics and AI-driven process optimization.
• Remote monitoring and real-time compliance dashboards.
• Increased emphasis on data integrity standards and global harmonization.

Conclusion

Enterprise Chromatography Solutions from Thermo Fisher Scientific offer a comprehensive approach to regulatory compliance and data integrity, enhancing laboratory productivity and resilience in a rapidly evolving regulatory landscape. Implementing Chromeleon CDS simplifies audit readiness, accelerates innovation, and secures trust in analytical results.

References

• Thermo Scientific Enterprise Chromatography Solutions White Papers
• Case Study: Sterling Pharma Solutions
• Case Study: Millipore Sigma