Transval is a software dedicated to the confirmation that an analytical method could be transferred based on Total Error concept.

An analytical transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The experiments performed in such a transfer and the methodology used to accept or reject it should be fitted for purpose. It is highly critical to have all the guarantees that the method is mastered by the receiver in order to avoid problems in the future.

As it is for method validation, total error-based approach should be also considered in method transfer. Indeed the classical approaches based on the separate evaluation of bias and precision (Hypothesis tests such as Student t-tests, or equivalence tests like TOST for bias,...) do not allow to make the adequate risk based decision. The β-expectation tolerance interval similar to the one used in method validation is calculated and then compared to acceptance limits around the estimate of the true value. This approach is about checking whether most of the results produced by the receiver will be close enough to the average result of the sender.

TRANSVAL is dedicated to the transfer of quantitative analytical methods in these highly critical situations.

Features:

The objective of Transval is to allow the user to apply easily the statistical methodology for the transfer of any quantitative analytical methods, and to provide users with a ready to file transfer report.
The main features of Transval are:

Transfer design: Transval allows the evaluation of the transfer towards up to 5 laboratories and can evaluate different concentration levels.

Transfer Profile: For every receiving laboratory, the corresponding transfer profile based on total error is calculated (graphical representation) and serves as decision tool.

Estimation of trueness, precision and accuracy: The optimal estimation of the main criteria required for the transfer in accordance with regulatory documents such as ICH Q2R1 and ISO.

Risk estimation: The risk of having Out Of Specifications results at each receiving lab is known.

Reporting: A transfer report containing the whole information required to judge the acceptability of the method transfer.

 

Screenshots & Technical sheets of Transval: English

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