Eurachem Releases New Guide on Fitness for Intended Use of Analytical Equipment

Eurachem has published a new guide titled The Fitness for Intended Use of Analytical Equipment and Systems – A Laboratory Guide to the Life Cycle of Analytical Equipment and Systems, their Qualification and Related Topics. The document was developed by the Eurachem Analytical Equipment and Systems Qualification (AE&SQ) Working Group and builds on concepts presented at PharmaLab 2024 by Ernst P. Halder, Chair of the working group and editor of the guide.

The guide addresses a broad range of analytical equipment, from simple instruments to complex computer-controlled systems, and covers the full life cycle—from design and procurement through qualification, operation, requalification, and decommissioning. Key topics include risk-based qualification approaches, Design, Installation, Operational and Performance Qualification (DQ, IQ, OQ, PQ), data integrity and ALCOA+ principles, calibration versus long-term performance monitoring, and alignment with standards such as ISO/IEC 17025, ISO 15189, GMP, and GLP.

Alongside the guide, Eurachem also released a concise leaflet introducing the core principles of fitness for intended use. The first English edition (2025) is available for download from the Eurachem website, and user feedback is encouraged.

08-02-2026