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Requirements management for further development of a diagnostic tool
Project duration: 6 months
Brief description
Software is further developed for a tool that has been on the market for several years. A subproject of this update is to reflect existing requirements and their traceability in compliance with FDA, and to record new requirements in these activities. At the same time, the requirements management process is to be checked and adjusted, if necessary, with regards to the FDA and internal quality guidelines.
Supplement
Requirements are entered and managed in HPQC 10 based on customer wishes. The project uses the waterfall model within a highly-regulated environment.
Subject description
For the availability analysis, the traces are exported to Excel, targeted and evaluated. Processes relevant to requirements management are defined in compliance with the FDA and internal quality guidelines and reconciled within the project and with the Quality Assurance department.
Overview
- Industries pharmaceutical industry
- Specialist tasks FDA validation, laboratory systems, quality management
- DV tasks Requirements Engineering
- System environment standard software: industry systems
- Procedure model Waterfall Model
- Development/ test tools HP Quality Center
Project period03.03.2014 - 31.08.2014
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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