Roche Diagnostics provides products and services for the prevention, diagnosis and therapy of illnesses for researchers, doctors, patients, hospitals and laboratories worldwide and is the world leader in the area of in-vitro diagnostics.
This also includes the automatic analytical systems of the Elecsys range for the immunological diagnostics, which is used to rapidly detect over 80 different diagnostic parameters from blood or other samples from patients.
In order to achieve the required accuracy, the reagents used cannot simply be produced by using a fixed formula of the source materials, but rather the ratios of concentration must be empirically determined and optimised with each production batch.
In this procedure, the „In-Process Control (IPK)“, different variants of the reagents are compared by means of experimental design and the optimal concentration is ascertained using variance analytical processes.
Roche Diagnostics commissioned us with the development of an appropriate software solution. 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.
In order to adapt the software to the requirements of the IPK department as well as possible, we provided the customer with several executable provisional versions. Automated Unit Tests examined the software quality respectively.