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
Roll-out SAP and EWM (Extended Warehouse Management) worldwide
A global pharmaceutical company is consolidating its SAP and EWM systems, which constitute the core company systems for the financial and especially the logistical processes. Existing legacy systems are to be replaced and their data migrated. QFINITY∞ provides project quality assurance for change management, document life cycle, testing and data migration.
Change to SAP S/4HANA for a globally established SAP R/3 system of a pharmaceutical company
SAP S/4HANA is the new version of SAP that brings fundamental changes in data management and requires extensive technical customization and testing as part of a technical update. As Validation Manager, QFINITY∞ ensures the quality of the upgrade, which also includes developing a plan for running parallel versions and, in particular, for updating the validation documents. The team uses the SAP smartShift Tool, which allows semi-automatic modification of the source code; qualifying the tool is part of the project.
Definition of the general procedure for the operation and the qualification of an IT infrastructure
Many companies have individual procedures for the operation and qualification of infrastructure components, but they often do not have a centralized, unified approach. QFINITY∞ conducts training on infrastructure control requirements at a pharmaceutical company and builds on it to create comprehensive SOPs and templates.