VALIDAT Laboratory Software for Method Transfer
When is method transfer necessary?
Method transfer, i.e. the transfer of analytical procedures, becomes necessary when tests are transferred to additional internal or external labs. Problems regarding comparability of results repeatedly arise as a result of this. The method transfer should be planned and implemented at an early stage. Only once the evaluation has been completed can it be ensured that the results from the various labs are comparable.
VALIDAT laboratory software supports this requirement by means of stored templates created on the basis of a completed risk assessment. The method transfer can then be automatically planned by VALIDAT laboratory software for message transfer, for the laboratories affected. The tasks are distributed among the laboratories manually or on the basis of existing interfaces to the LIM systems or measuring instruments (e.g. CDS).
Measurements are imported from VALIDAT manually or automatically and are evaluated. Statistical and graphical evaluation is then performed to determine whether the laboratories involved are delivering comparable results. An extensive message transfer report containing all measurements, 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 process, the number of batches, the number of samples, the acceptance criteria and the schedule are determined in the templates of the laboratory software for method transfer. Transfer projects can then be created based on the templates and adjusted in line with a risk assessment if necessary. Tasks are promptly forwarded to the labs affected. As part of this process, data can also be imported from external systems (methods from the LIMS, CDS, etc.) and the necessary samples, measurements and sequences provided.
Adopting the measurements in VALIDAT
The measurements can be manually or automatically imported into VALIDAT laboratory software, together with all the necessary information. Calculations and evaluations are performed automatically. Unexpected deviations are marked and displayed directly. This may lead to the expansion of the project and may trigger additional activities. All changes and status changes are logged and require electronic signature (21 CFR Part 11).
Completion of the project and reporting
Once all the necessary measurements have been completed and evaluated, the report containing all the required information can be created as a Word document based on the preferred template. The report is stored in the DMS, and every change is logged.