Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 compliant laboratories

Importance of the Topic

In regulated laboratories, especially in pharmaceutical and environmental analysis, ensuring the integrity, authenticity and traceability of electronic records is essential. Techniques such as ICP-OES and ICP-MS play a critical role in monitoring toxic elements like arsenic, cadmium, mercury and lead. Adherence to 21 CFR Part 11 and similar international guidelines safeguards data quality, protects public health and supports compliance audits.

Objectives and Overview

This technical note evaluates how Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software addresses 21 CFR Part 11 requirements. It reviews the software’s features for audit trails, electronic signatures, user access controls and data management. The goal is to demonstrate a turnkey platform that unifies workflows across ICP-OES and ICP-MS instruments while maintaining regulatory compliance.

Methodology and Instrumentation

The Qtegra ISDS platform was developed under ISO 9001 procedures at Thermo Fisher’s Bremen facility. Rigorous IQ/OQ processes verify software installation integrity and algorithm performance using checksum validation and example datasets. The software interfaces with Thermo Scientific Qnova ICP-MS and ICP-OES systems, offering consistent workflows and method templates across instruments.

Main Results and Discussion

Qtegra ISDS implements closed-system controls including encrypted LabBook containers for all records, built-in checksum scans at launch, and automatic backup options. Unique user IDs and Windows-based authentication prevent unauthorized access, while detailed audit trails capture all changes with user, timestamp and reason. E-signatures require two-component authentication and are embedded in the data container, ensuring traceability. Operational checks such as automated Get Ready routines enforce instrument performance criteria before analysis.

Benefits and Practical Applications

• Unified software for ICP-MS and ICP-OES simplifies training and reduces method development time.
• Comprehensive audit trails and encrypted storage ensure data integrity throughout retention periods.
• User-defined templates and automated QC checks minimize manual interventions and potential errors.
• E-signature workflows support multi-level review and compliance with the four-eyes principle.

Future Trends and Applications

As regulatory frameworks evolve globally, integration of cloud-based data management and advanced AI-driven anomaly detection will further enhance compliance and analytical efficiency. Expanded interoperability with Laboratory Information Management Systems (LIMS) and digital certificates will support broader adoption of electronic workflows.

Conclusion

Thermo Scientific Qtegra ISDS Software offers a robust instrument-agnostic platform that meets stringent electronic record requirements under 21 CFR Part 11 and analogous regulations. Its integrated audit trails, secure data containers, flexible user controls and e-signature capabilities provide laboratories with the tools needed for reliable, compliant trace element analysis.

References

• 21 CFR Part 11, Title 21 Code of Federal Regulations, U.S. Food and Drug Administration.
• ICH Q7 and EU Annex 11 Good Manufacturing Practice guidelines.
• Thermo Fisher Scientific. Qtegra ISDS Software Technical Note 43106 (2019).