Fitness for the intended use of analytical equipment and systems

Importance of the Topic

The qualification and fitness for intended use of analytical equipment and systems underpin reliable laboratory results. Ensuring that instruments perform consistently under defined conditions is essential for accurate chemical analysis, regulatory compliance and data integrity across sectors such as pharmaceuticals, environmental monitoring and quality control.

Objectives and Study Overview

This document, produced by the Eurachem Analytical Equipment and Systems Qualification Working Group, aims to outline principles and best practices for demonstrating that analytical equipment and systems meet laboratory needs. It introduces life-cycle concepts, quality pyramids and considerations beyond mere calibration.

Methodology and Instrumentation

The approach consists of:

• Defining user requirements (URS) covering operational ranges, data integrity and system interfaces.
• Qualifying equipment performance during installation, operational and performance qualification phases.
• Validating analytical methods and assessing robustness to variable conditions.
• Implementing quality control measures at short-term (internal) and long-term (inter-laboratory) levels.

Analytical instrumentation includes spectrometers, chromatographs and other measurement systems requiring traceable calibration and stability monitoring.

Main Results and Discussion

The pyramid of quality emphasizes that equipment qualification (level 1) and method validation (level 2) must be defined and controlled before implementing quality assurance. Calibration alone does not address environmental fluctuations or instrument drift; robustness testing and equipment qualification fill these gaps. A life-cycle model highlights the impact of URS on procurement, operation, maintenance and decommissioning.

Benefits and Practical Applications

• Improved confidence in analytical results through documented qualification and validation.
• Regulatory compliance with ISO/IEC 17025 and sector-specific standards.
• Enhanced data integrity and traceability across the equipment life cycle.
• Optimized resource use by defining service life, maintenance schedules and data retention policies.

Future Trends and Opportunities

Emerging practices include digital twins for predictive maintenance, AI-driven monitoring of instrument performance and standardized guidance for complex multi-component systems. Integration of advanced data management platforms will support greater transparency, sustainability and cross-laboratory consistency.

Conclusion

Establishing fitness for intended use requires a comprehensive framework extending beyond calibration to embrace URS, qualification, validation and ongoing quality assurance. Adoption of life-cycle and pyramid-based approaches enhances reliability, regulatory adherence and efficient laboratory operations.

Reference

1. Schwedt G. The essential guide to analytical chemistry, 1997.
2. ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.
3. JCGM 200:2012 International vocabulary of metrology (VIM).
4. ISO 9001:2015 Quality management systems – Requirements.
5. ISO 10012:2003 Measurement management systems – Requirements.
6. ISO 17034:2016 Competence of reference material producers.
7. ISO 17043:2023 Proficiency testing providers requirements.