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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
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.