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.
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.
Auditing of the GVP processes and the underlying computer-aided systems at a pharmaceutical manufacturer
A pharmaceutical manufacturer hires QFINITY∞ to conduct a routine audit of the pharmacovigilance system to verify compliance with regulatory requirements. The audit also includes the relevant computerized systems that influence processes in the pharmacovigilance area, as well as the special role of a qualified person in the company.