Support of development transfer for a diagnostic small device
Project duration: 7 months
Brief description
To expand its portfolio, the customer has acquired a development company and is planning to transfer production, support and further development from the USA to Europe within a year. Providing a risk/expense appraisal to transfer quality-related and regulatory-related documents and artifacts to the new environment.
Supplement
A purely document-based development is to be transferred to the customer's existing tool environment with the minimum possible effort but in an audit-proof manner. It should be possible to easily identify and eliminate gaps and redundancies with the procedure that is to be developed. Within the order, existing quality-relevant documents are viewed and categorized and a cost estimate is created for their transfer/revision. A built-in risk analysis forms the basis for a project plan to be both created and approved by the customer. Furthermore, the IT development environment (HPQC + TFS) is set up, configured and assigned various synchronization jobs.