Roche Diagnostics commissioned us with the development of an appropriate software solution for the „In-Process Control (IPK)” for the assays of the Elecsys device series. JMP, a SAS tool for the interactive analysis of data, was chosen as the basis. Control files ease the configuration of the system. JMPs own scripting language automates the processes. The calculation software of the Elecsys devices is directly integrated through interfaces. The result is printable reports supplied by JMP with unambiguous recommendations for the composition of the reagents, as well as with results in terms of the compliance of test criteria.
The manufacturer of medical devices, Roche Diagnostics GmbH, together with HMS Analytical Software GmbH, have jointly developed an innovative server platform within the medical industry that not only meets the demands of production processes of larger medical technology manufacturers, but also fulfills the requirements for validated systems as set by the regulatory authorities.
HMS analysed the data management work flow at CRS and on this basis developed a catalogue of measures, which involved the deployment of SAS Clinical Standards Toolkit during compliance testing according to the SDTM Standard and for the preparation of the Define.xml.