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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
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.
GCP Audit of Processes and Computerized Systems at an academic CRO
An academic CRO contracts QFINITY∞ to audit its GCP processes for compliance with regulatory requirements. The audit also included the processes and validation status of computerized systems used for data management and statistical analyses.