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
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.
Development of a validation framework and validation of Open-Source EDC software for a European physicians’ association
A European contract research organization (CRO), associated with an association of European physicians, needed to validate its open-source data collection system (EDC) for conducting clinical trials. QFINITY∞ trained the organization’s employees in the basics of GxP, CSV, and Part 11, provided the necessary SOPs and templates for validation and operation, and supported the ongoing validation of the EDC system (OpenClinica) through coaching.