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Electrolyte Analyzer
Project duration: 1 year, 5 months
Brief description
The software update for the Electrolyte Analyzer leads to an increased throughput and enhanced connectivity. This facilitates the simultaneous loading of up to 96 samples. In this project, the PTA is tasked with the creation and implementation of necessary requirements. Additionally, the PTA conducts risk management in accordance with ISO 14971.
Supplement
The system environment leverages a customized Linux platform and is implemented using the C programming language. The Risk Management analysis has been crafted based on the FMEA methodology, incorporating the creation of Risk Control Measures. All requirements and Risk Control Measures are logged in HP ALM, with verification meticulously documented.
Subject description
The product is utilized in the development of novel compounds within bioreactors. Precision in adjusting nutrient concentrations within the bioreactors is crucial to ensure that the proliferating cells are optimally geared towards achieving maximum compound output.
Overview
- Branchen pharmaceutical industry
- Fachaufgaben ISO 14791, risk analysis, Risk Management, statutory health insurance, System Engineering
- DV-Aufgaben customised software further development
- Systemumgebungen Client/Server
- Vorgehensmodell V-Modell
- Entwicklungs- und Testtool GitHub
Project period01.05.2020 - 30.09.2021
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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