QFINITY · News · Insights & Events
Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
Latest articles
SAP Release Change at a pharmaceutical manufacturer
The client plans to upgrade its SAP system landscape (using SAP S/4HANA in-memory database technology) and wants to use this opportunity to improve the company’s approach to implementation, validation and operation of these systems. QFINITY∞ will provide strategic and conceptual support for this project.
Audit of an electronic batch record (EBR)
Our medical technology client wants to establish the electronic batch record as the central tool for production documentation (including archiving). The commissioned audit will verify the regulatory compliance (USA / EU) of the implementation project, the computerized processes for producing an electronic batch record and the implementation of the process in an electronic tool (SAP), while also checking for weaknesses in the logistics workflow.
Implementation and Validation of an UDI-Solution
Strategic and operational support for a project to implement a system landscape for automated transfer of product information to the FDA. The project was intended to lay the technological foundation for the automated transfer of product data from an SAP system to the FDA’s GUDID via an external gateway.