QFINITY · Updates
The latest from QFINITY and the field.
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
At a glance
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
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).
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.