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New validation tool now in operation

Planning validation studies remains a difficult topic, especially for ad-hoc requirements and where fitness-for-purpose is the principal issue. In 2003, VAM introduced mVal: a software package that guides users through the processes for carrying out planned validation studies. However, there remains a need for readily available guidance on planning validation.

LGC has launched a new method validation online support tool, mVadvisor. Developed as part of the VAM Programme and in collaboration with the scientific software developer Tessella, mVadvisor allows users to tailor validation planning to particular problems. Users are led through a set of questions relevant to planning: the software provides intelligent selection of performance characteristics in response. Alternatively, users can select one of several predefined protocols relevant to regulatory applications.

mVadvisor incorporates validation advice based on internationally agreed best practice. It also includes calculation tools that help users decide on the appropriate number of replicates, and decide on the optimal uncertainty for their particular application. The software includes support for validation planning based on the ICH series of protocols appropriate for regulatory work in the pharmaceutical industry.

mVadvisor is also effective as a training tool. The glossary, definitions and explanations of method validation terminology and concepts allow new users to develop a structured approach to validation planing and develop an awareness of the rationale for appropriate choice of experimental conditions. The replicate calculator provides an interactive introduction to the process of selecting replicate numbers, while the �false response rate� calculator interactively demonstrates the practical effects of improved uncertainty.

mVadvisor complements VAM�s other method validation products, including mVal. mVadvisor provides protocol descriptions in XML format, allowing mVal users to copy, save and import their plans without the need to transfer detailed settings.

mVadvisor is available on the VAM Website at www.vam.org.uk/mvadvisor.

Other method validation products available

mVal: Software for analytical method validation

In-house method validation: A guide to chemical laboratories

The fitness for purpose of analytical methods: A Laboratory Guide to Method Validation and Related Topics

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