The Development and Application of Guidance on Equipment Qualification of Analytical Instruments

Date: 30/11/1996	Ref No:	Type: Guide
Author(s): Bedson P, Sargent M
Organisation/Publisher: LGC

This document provides guidance on equipment qualification (EQ) of analytical instruments. Equipment qualification is a formal process that provides documented evidence that an instrument is fit for its intended purpose and kept in a state of maintenance and calibration consistent with its use. The guidance defines a general approach to EQ based on four stages of qualification; design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and is widely applicable to a range of instruments commonly used in analytical laboratories. The guidance was prepared by LGC in collaboration with the VAM Instrumentation Working Group, a committee comprising a cross-section of users, suppliers and manufacturers of analytical instruments along with representatives of regulatory authorities and accreditation bodies.