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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
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.
Introduction of SAP Governance, Risk & Compliance (GRC)
Authorization management, especially critical access and segregation of duties (SoD), is a central focus of audits. Many companies therefore implement central solutions to technically support or control these processes. The global ERP system is particularly important here. Introducing SAP Governance, Risk & Compliance (GRC) has become an integral part of the SAP lifecycle, as it supports processes such as change management centrally and in a system-oriented way. As technical expert and project manager, QFINITY∞ is introducing SAP CHaRM (Change Request Management) for various SAP systems around the world at one of the leading pharmaceutical manufacturers.