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Defining (new) requirements for a diagnostic analysis device for integrated serum workplaces
Project duration: 8 months
Brief description
In order to get a long-running project that is in difficulties back on track before the design input, existing requirements for a diagnostic analysis device that have been identified as incomplete, misleading or contradictory are revised, or amended or replaced by newly determined, checked, coordinated and documented requirements. Given the strongly regulated environment in which the project is located, all quality-related and regulatory-related documents and artifacts are generated in an audit-proof manner and transferred to a customer-specific administration environment.
Supplement
In addition, the requirements and their traceability and the project-specific risks are managed and appropriate measures are identified to mitigate risks.
Subject description
As part of a high- to medium-throughput product family for integrated serum workplaces, the diagnostic analysis device covers a wide range of clinical-chemical and immunological analyses.
Overview
- Industries pharmaceutical industry
- Specialist tasks Audit, laboratory systems, quality management, risk analysis
- DV tasks customised software support
- System environment organizational consulting
- Procedure model V-Modell
Project period01.01.2015 - 31.08.2015
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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