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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.
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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).