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
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.
Data Governance and Data Integrity at a large pharmaceutical company
QFINITY∞ lays the groundwork for establishing and implementing a comprehensive set of guidelines for meeting data governance and data integrity requirements effectively and in a company-specific way at a large, corporate-affiliated pharmaceutical company.
Track & Trace for a phytopharmaceutical manufacturer
QFINITY∞ supports the introduction and implementation of a concept for the regulation-compliant rollout of “track and trace”. Based on the legal requirements, QFINITY∞ developed a concept in close cooperation with the client that also gives smaller manufacturers an economical way to meet legal requirements.