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What is driving the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI. They cover what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
Latest articles
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.
Preparation of a Service Level Agreement (SLA)
Under the requirements of Annex 11, implementing a Service Level Agreement (SLA) between the business department and the IT department is essential. QFINITY∞ supports a pharmaceutical manufacturer in preparing and coordinating the contents of the SLA.
Production optimization at a North German manufacturer of phytopharmaceuticals
QFINITY∞ supported the optimization and rationalization of the bottling and packaging line throughout the entire project, from preparing the specifications and selecting the system to completing the validation activities.