VALIDAT Method Transfer Lab Software
When is a method transfer necessary?
Method transfer, i.e. the transfer of analytical procedures, becomes necessary when the tests are transferred to other internal or external laboratories. As a consequence, problems with the comparability of the results occur again and again. Method transfer should be planned and carried out at an early stage. Only after the evaluation can it be ensured that the results of the different laboratories are comparable.
The laboratory software VALIDAT supports this requirement by means of stored 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 manually or automatically transferred and calculated by VALIDAT. Then a statistical and graphic evaluation and assessment is automatically carried out to determine whether the laboratories involved provide comparable results. In addition, a comprehensive report on the method transfer, including all measured values, calculations, formulas, graphics etc., can be created, documented and distributed at any time.
Transparency and security
Planning of a method transfer project
In the templates of the method transfer laboratory software, the number of batches, the number of samples, acceptance criteria as well as the time schedule are specified in addition to the statistical procedures. Transfer projects can then be created on the basis of templates and, if necessary, adapted according to a risk analysis. The tasks are promptly passed on to the laboratories concerned. Data from external systems (methods from LIMS, CDS, etc.) can also be transferred via interfaces and the necessary samples, measurements and sequences can be provided.
Transfer of the measured values to VALIDAT
The measured values can be transferred manually or automatically with all necessary information to 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).
Project completion and reporting
Once all necessary measurements have been carried out and evaluated, the report can be created as a Word document with all information based on the desired template. The report is stored in the DMS and every change is logged.