Auditing the clinical data management process of a university institute, including checking the validation documents of an Open-Source EDC software

A university institute (CRO) wished to perform clinical trials with an Open-Source electronic data capture (EDC) system. QFINITY∞ was commissioned by the QA department of the university to perform an audit concerning the compliance of the validation project and the validation documents for the EDC system, as well as other regulatory documents necessary for conducting clinical trials.