Validationpreparation for GxP compliance of a Lab Information Management System

To expand the market access for a successful LIMS, the manufacturer is requested to prove that the basic requirements of GxP guidelines can be fulfilled with the existing LIMS. Essentially, this means access control to result-relevant datasets, traceability of changes and the restriction of functionality to the defined processing sequences. PTA creates generic validation test cases, which are executed against defined configurations. The test run outcome is used to improve the system with respect to GxP requirements but also as a proof against the user that compliance can be achieved by configuration.