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Process migration
Project duration: 9 months
Brief description
As a consequence of a reorganisation at the customer, the product risk management process had to be optimized and mapped in the HP-ALM supported web interface WebIT.
Supplement
The activity included the process analysis of existing risk management processes. Furthermore, an optimum was to be sought that would meet the requirements of the various projects and at the same time satisfy the new regulatory requirements. To this end, existing QAPs and SOPs and the associated templates and associated IT systems were revised. For this purpose, the data model of various affected projects had to be analysed, specifications had to be collected and coordinated with the various stakeholders. The final specifications were then optimised with the developers of the IT support and tested extensively after the implementation before the final release of the system.
Subject description
The processes and the associated templates and tools have an important regulatory position. Risk Management (ISO 14971) has a fundamental role in IVD products and is the focus of every process and product audit.
Overview
- Industries pharmaceutical industry
- Specialist tasks quality assurance, Total Quality Management, validation
- DV tasks concept
- System environment Business Intelligence
- Procedure model SA/SD (structured analysis and design)
Project period01.06.2017 - 01.03.2018
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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