Context

The goal of the project was to provide data from the production lines of QIAStatDx – Cartridges in a validated form in the Azure Cloud. For this purpose, a modular interface was developed. Some modules (plugins) are completed, while others are still in the conceptual phase.

Figure: Modular structure of the interface. Division into Core development, Plugin development, and a Configuration Layer to adapt the plugins to local requirements. As a result, rollouts with projects that only need configuration can be implemented – facilitating validation.

Tasks

• Technical concepts (Generic programming, Virtualization, Digitalization, Docker…)
• Technical lead for project implementation
• Requirements Engineering for OPC/UA Client
• Development of a validated back end for an „Analytics Interface“ (.NET Core / Azure / Docker)
• Frontend development of the R&D platform „Manufacturing Radar“ (C# / ASP.NET Core / Razor Pages)
• Creation of URS, SDS, FDS (User Requirements Specification, Software Design Document, Functional Design Specification), Risk Matrix.
• Creation and processing of GMP-relevant qualification documents (DQ / IQ / OQ / PQ)
• 3rd Level Support

Generic Interfaces

The following plugins have been implemented so far:

• DbTransfer (SQL – Transfer, currently MSSQL and MariaDB)
• CSV – File Interface
• OPC/UA Interface
• Computer Vision – Integration
• Image Upload Azure BLOB
• Data Upload Azure Event Hubs
• Data Upload Azure IOT Hubs

Technical Environment

• NET Core 6.0
• Windows Service
• Azure DevOps
• Azure Cloud (IOT Hub, Event Hub, BLOB Storage)
• MSSQL / MariaDB