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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
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.
Online Training Asia/Pacific
Medical technology company contracts QFINITY∞ to plan and conduct online training sessions for employees of its IT departments, including adapting the existing training materials for online delivery.