Eurachem Publishes New Guide on the Fitness for Intended Use of Analytical Equipment and Systems

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 is the result of intensive work by the Eurachem Analytical Equipment and Systems Qualification (AE&SQ) Working Group.

The core concepts of the Guide were previously presented to the professional community at PharmaLab 2024. During the Analytical Instrument Qualification and System Validation track, Ernst P. Halder, Chair of the Eurachem AE&SQ Working Group and Editor of the Guide, outlined the background, objectives, and key ideas behind the Eurachem work on the fitness for the intended use of analytical equipment and systems.

In parallel, Eurachem published a leaflet on the fitness for the intended use of analytical equipment and systems. This concise document introduced the fundamental principles of fitness for intended use, highlighted the role of analytical equipment in producing reliable results, and pointed to the need for an integrated, risk-based approach that goes beyond calibration alone.

Scope and Key Content of the new Guide

The document addresses a wide range of analytical equipment, from simple instruments to complex, computer-controlled systems combining hardware and software. It covers the complete life cycle, starting with design, development, and manufacture, and extending through purchasing decisions, installation, operation, maintenance, requalification, and decommissioning.

Key topics include:

• the role of analytical equipment within the overall analytical process and the “pyramid of quality” supporting reliable reportable results
• life-cycle concepts such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• risk-based approaches to defining the scope and depth of qualification for different types of equipment
• the interaction between equipment qualification, analytical method validation, robustness testing, and measurement uncertainty,
• calibration versus long-term performance control and trend evaluation
• data integrity and traceability, including the application of ALCOA+ principles
• alignment with international standards (e.g. ISO/IEC 17025, ISO 9001, ISO 15189) and regulatory frameworks (GMP, GLP, pharmacopoeias)

Structure

Eurachem has structured the Guide to lead the reader from general principles to practical implementation across the full equipment life cycle:

• Summary – outlines the concept of fitness for intended use as a prerequisite for valid, reportable analytical results.
• Scope – defines what is meant by analytical equipment and systems and clarifies applicability across different laboratory environments and standards.
• Introduction – explains the role of analytical equipment in the measurement process, provides historical background, and introduces the “pyramid of quality” supporting reliable results.
• General Principles – describes regulatory and standards-based requirements, digital control and software aspects, traceability, data integrity (ALCOA+), documentation, risk assessment, and the scope of qualification.
• Life Cycle of Laboratory Equipment – the core chapter, covering Design Qualification (DQ) and User Requirements, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), maintenance of the qualified state, requalification, and decommissioning.
• Appendices – include relevant standards and regulations, acronyms and terminology, abbreviations, and references.

Download

The first English edition (2025) is available for download from the Eurachem website. Feedback from users is explicitly encouraged and can be submitted via the Eurachem AE&SQ Working Group contact channels.