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
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.