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
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).
Training und Workshop at a Contract Research Organization (CRO)
CRO contracts QFINITY∞ to plan and conduct basic training in the validation of computerized GCP systems. A supplementary workshop analyzed the established QM system to identify significant weaknesses.
Regulatory Compliance Check bei einer Contract Research Organisation (CRO)
CRO contracts QFINITY∞ to plan and conduct regulatory compliance checks.