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3rd level support for diagnostics middleware
Projektdauer: 3 Jahre, 10 Monate
Kurzbeschreibung
In this project, support will be provided for complaint handling in the 3rd level support of a laboratory middleware in the framework of a regulated environment and the customer-specific quality management system.
Ergänzung
Error reports found during routine operation are continually filtered and forwarded by the 2nd level support, and should be examined in a coordinated manner on the basis of the customer's process model. The core task includes the technical analysis and reproduction of the error and locating the cause of the problem at the code level. Furthermore, a risk assessment is carried out and, based on this, further measures are introduced to track and document serious errors and the correction of these. 1st and 2nd level support, testers, and developers are given support with the further steps. New comers to the team are trained (product environment, and processes) to be able to process the number of errors experienced by a growing number of end users in a timely manner.
Fachbeschreibung
The software product was developed on the basis of a milestone-based quality management system in order to satisfy the requirements on medical products (and IVDs) specified by the FDA or SwissMedic. By the processing of patient and diagnosis data within the product, processes such as risk management and FMEA must be taken into account, checked, and their effects documented, also in the maintenance phase.
IT-Projektdaten
- Branchen Pharma-Industrie
- Fachaufgaben complaint management, laboratory systems, Support
- DV-Aufgaben Individualsoftware-Support
- Systemumgebungen Internet/Intranet, technical data processing
- Vorgehensmodell customer standard
- Entwicklungs- und Testtool MS Visual Studio, PL/SQL-Developer
Projektzeitraum01.03.2012 - 31.12.2015
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