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Specification of control software for a clinical pooling instrument
Project duration: 5 months
Brief description
The customer manufactures a pooling instrument for the international market that needs to fulfill FDA requirements. PTA supports the customer in the field of software development in formulating the requirements, and revising and completing traceability within the requirements, test cases and risks.
Supplement
TThe requirements are managed with HP ALM and they need to correspond to a sentence template. This sentence template is specified by the customer but it was not fully complied with during development of the first version. When the requirements are drawn up again and reformulated, it is important for the semantics of the individual requirements to be retained or extended. For additional support, UML models are developed, updated or corrected in Enterprise Architect. Traceability is ensured by connecting requirements, test cases and risks to HP ALM. Compiling these requires intensive discussions with all stakeholders and is supported by a variety of quality assurance measures.
Subject description
Samples are analyzed and tested in clinical laboratories. In laboratories for blood donation services, such as the Red Cross, in particular, very large quantities of samples are tested each day. However, as the number of reactive samples is relatively small, the aim is to make the throughput as high as possible. For this reason, multiple samples are pipetted into each sample tube. These sample tubes are called pool tubes. These contain 96 samples, for example, which are analyzed simultaneously. If all the samples in this pool tube are negative, it is possible to state that all 96 samples are OK using just one test. If at least one sample is positive, resolution tubes are requested. These sample tubes contain a different combination of 12 samples in a pool sample. Provided that the expected rate of positive test results is very small, this method increases the throughput rate in a laboratory.
Overview
- Industries pharmaceutical industry
- Specialist tasks FDA validation, validation
- DV tasks quality management
- System environment Client/Server, component technology, technical data processing
- Procedure model agile software development
- Development/ test tools MS Team Foundation Server TFS
Project period06.10.2014 - 28.02.2015
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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