Validation of a customized LIMS.

The advantages of customized Laboratory Information Management's Systems (LIMS) are their focus on the special aspects of their users' needs. Differences in the research and development or production chain in the individual organizations lead to an increase of interest in customized systems. Usually, also for customized systems, the core software is commercially available. The individual application modules as the Customized part of the LIMS are the most critical elements within the validation process. The topic of this paper is to give an example of the validation of a customized analytical LIMS. Validation of complex computerized systems guarantees the intended use and is therefore an unavoidable requirement of authorities. The audit of the supplier of the individual programmed modules, the user requirement specifications and the acceptance testing and results, respectively, on the software are of special interest within a customized LIMS. The hardware suitability and the principal processing routines are also a very important part of the whole validation process, but they will not be discussed in detail in this paper.

[High-resolution magnetic resonance tomography of the lesser pelvis using an endorectal coil]. / Hochauflösende Magnetresonanztomographie des kleinen Beckens mittels Endorektalspule.

Spatial resolution of MRI within the true pelvis can be increased by a factor of 12 using an endorectal coil. The value of this new method for demonstrating the prostate, the rectum, the cervix and vagina and of pathological processes of these organs was examined in 89 patients and the results compared with conventional body coil MRI. In 25 patients who underwent radical surgery the results of the preoperative studies were compared with the histological findings. Detailed recognition of anatomical structures was markedly improved by using the endorectal coil. Diagnosis of carcinoma of the prostate and extension of the tumour was accurately assessed in 33 patients. Preoperative staging was correct in 87%, compared with 73% when using a body coil. The difference was less marked in examinations for carcinomas of the rectum, the cervix and vagina. Nevertheless, staging was more accurate in a few cases with a better recognition of recurrences. MRI with endorectal coils will have an important role in diagnosis of carcinomas of the prostate in the future. Its use in the diagnosis of carcinomas of the rectum and cervix must be subject to further studies.