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.
Track & Trace for a phytopharmaceutical manufacturer
QFINITY∞ supports the introduction and implementation of a concept for the regulation-compliant rollout of “track and trace”. Based on the legal requirements, QFINITY∞ developed a concept in close cooperation with the client that also gives smaller manufacturers an economical way to meet legal requirements.
Development of a validation framework and validation of Open-Source EDC software for a European physicians’ association
A European contract research organization (CRO), associated with an association of European physicians, needed to validate its open-source data collection system (EDC) for conducting clinical trials. QFINITY∞ trained the organization’s employees in the basics of GxP, CSV, and Part 11, provided the necessary SOPs and templates for validation and operation, and supported the ongoing validation of the EDC system (OpenClinica) through coaching.
Auditing the clinical data management process of a university institute
A university institute (CRO) wanted to conduct clinical trials with an open-source electronic data capture (EDC) system. The university’s QA department commissioned QFINITY∞ to audit the compliance of the validation project and the validation documents for the EDC system, as well as other regulatory documents required for conducting clinical trials.