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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.
Latest articles
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.
Auditing of the GCP processes at a university KKS and its university partner organisations
A coordination center for clinical studies in the university sector commissions QFINITY∞ to audit its GCP processes. The audit also includes two partner institutes of the university that are responsible for statistics and data management and examines the computerized systems used and their validation.