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
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.
Workshop Audit Trail Review
Due to the requirements of Annex 11 regarding audit trail review, companies are increasingly trying to standardize their procedures. Especially with complex systems like ERP (Enterprise Resource Planning), different aspects of the system have to be considered. As part of the rollout of a new ERP system, QFINITY∞ collaborates with a pharmaceutical company to define a process for this activity.