Processdefinition for migration of laboratory information systems

The configurations of the laboratory information system which need to be migrated contain several hundreds up to thousands of settings. All these information are potential subject to be documented and checked. Currently the information are collected in an unstructured way, more likely they are discovered by malfunctions of the migrated system just before 'go-live'. This leads to shifting timelines, time-consuming reverification activities as well as to changing customer requirements. As the laboratory information systems are used in diagnostic environment, the documentation with respect to computer system validation (CSV) is mandatory. Therfore the PTA customer aims to improve its own output qualification (OQ) as well as the preparation for the performance qualification (PQ) of the final user.