NEW VAM GUIDE AND SOFTWARE PACKAGE TO AID IN-HOUSE METHOD VALIDATION STUDIES
14 October 2003 - LGC

The guide, entitled In-house method validation: a guide for chemical laboratories, was produced in response to requests from small laboratories for user-friendly advice on conducting in-house method validation studies. It provides advice on the concepts and good practice in method validation for quantitative chemical analysis, and includes discussion of laboratory accreditation requirements. The guide adopts a holistic approach to the inter-related topics of method validation, measurement uncertainty and traceability and takes into account cost-benefit issues when considering the degree of rigour required. It is short, easy to read and is colour-coded to allow ready access to topics of interest.

The new VAM software, mVal, is a powerful and flexible method validation management package, providing all the statistical tools necessary for fast and efficient validation. Developed for outstanding flexibility, mVal´s validation design module provides a unique ´building block´ approach to validation suite planning for complete tailoring to individual requirements; experiment types, performance characteristics, numbers of replicates, outlier testing - even the terminology can be adapted to suit the customer or regulator. mVal also allows import and export of protocols using the industry-standard XML format, allowing rapid transfer between users or even between user and customer. It is simple to apply; at the push of a button, analysts can select from predefined protocols or create their own for client or regulatory requirement.

Dr Steve Ellison, head of LGC´s Training, Quality and Statistics team (the team responsible for developing both method validation products), said: "Today´s analytical laboratories need to show that the results they report are obtained using valid methods. Validation studies are vital to providing this evidence. The new guide provides user-friendly advice on what needs to be done when undertaking in-house method validation studies while mVal is an effective tool to make in-house method validation more cost effective. We believe that both products will be of particular interest to small/medium analytical laboratories that serve varying client requirements."

Commenting on In-house method validation: A guide for chemical laboratories and mVal, Cliff Billings, Quality & Technical Manager for Chemistry for the STL Group, described the new products as: "Two practical and very user-friendly quality tools to illustrate and implement method validation."

Denis Walker, Director of DTI´s National Measurement System, which funds the VAM Programme, said: "Method validation has been a big issue within the analytical community for some time. Since its conception in 1988, the VAM Programme has been working tirelessly to promote the necessity for all analytical methods to be fully validated and has provided support, through seminars, training and collaboration on other publications. These two new, low-cost and easy-to-use products will enable more laboratories to undertake in-house method validation studies in an efficient and cost-effective manner."

Both products are primarily aimed at chemists, laboratory managers and quality assurance specialists. The guide will also be of interest to those who commission analytical laboratory work and who need to ensure that the analytical work they commission is fit for their intended purpose.

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