QFINITY · News · Insights & Events
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
SAP R/3 Validation at a Medical Technology Company
A reputable manufacturer of medical technology contracts QFINITY∞ to plan and support SAP R/3 validation activities.
IT-Compliance at a Pharmaceutical Manufacturer
A mid-size manufacturer of pharmaceuticals contracts QFINITY∞ to plan and execute a global validation strategy for all computerized systems.
QFINITY∞ consults about the 21 CFR Part 11 in the U.S.
A major U.S. pharma company commissioned QFINITY∞ to prepare an expert opinion on the implementation of FDA 21 CFR Part 11 / EU GMP Annex 11 for the introduction of an Electronic Clinical Supply Management system, including Interactive Voice & Web Response Services (IVRS / IWRS).