VALIDAT Method Transfer Lab Software
When method transfer is necessary
Methodtransfer, i.e. the transfer of analytical procedures, becomes necessary when tests are transferred to other internal or external laboratories. As a consequence, problems with the comparability of the results always occur. Method transfer should be planned and carried out at an early stage. Only after evaluation can it be ensured that the results of the different laboratories are comparable.
The VALIDAT laboratory software supports this requirement by deposited templates, which were created on the basis of a performed risk assessment. The planning of the method transfer can then be carried out automatically for the laboratories concerned by the VALIDAT method transfer laboratory software. The respective tasks are distributed to the laboratories manually or on the basis of existing interfaces to the LIM systems or measuring devices (e.g. CDS). The measured values are transferred and calculated manually or automatically by VALIDAT. Then a statistical and graphical evaluation and assessment of whether the participating laboratories provide comparable results is performed automatically. In addition, a comprehensive report on the method transfer, with all measured values, calculations, formulas, graphics, etc., can be created, documented and distributed at any time.
Transparency and security
Planning a method transfer project
In addition to the statistical procedures, the number of batches, the number of samples, acceptance criteria and the time schedule are also defined in the templates of the method transfer laboratory software. Transfer projects can then be created on the basis of templates and, if necessary, adapted according to a risk analysis. The tasks are passed on to the laboratories concerned in a timely manner. Data from external systems (method from LIMS, CDS, etc.) can also be transferred via interfaces and the necessary samples, measurements and sequences provided.
Transfer of measured values into VALIDAT
The measured values can be transferred manually or automatically with all necessary information into the VALIDAT laboratory software. Calculation and evaluation take place automatically. Unexpected deviations are directly marked and displayed. This can lead to an extension of the project as well as to further activities. Every change and status change is logged and requires an electronic signature (21 CFR Part 11).
Completion of the project and report generation
If all necessary measurements have been carried out and evaluated, the report can be created as a Word document with all information on the basis of the desired template. The filing is done in the DMS and every change is logged.
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