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
Implementation of a Field Service Management Solution based on Salesforce
To support its Field Service Management, a medical device manufacturer plans to implement a Salesforce-based software solution. The goal is primarily to collect information on key indicators. As part of this project, QFINITY∞ plays a supporting role, for example in analyzing the requirements, performing risk analyses, and ensuring GxP-compliant implementation of the system (Audit Trail, handwritten signatures on electronic devices). The project includes creating a GxP-compliant template for worldwide rollout (multi-site approach).
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.