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.
Audit of the Quality Management Processes of a small/midsize CRO
A small-to-midsize CRO contracts QFINITY∞ to conduct an audit of the quality management system in order to identify opportunities for improvement. The audit comprised all the processes associated with the QM unit and its documentation.
Audit of the GCP Safety Processes and the underlying computerized systems of a small/midsize CRO
A small-to-midsize CRO contracts QFINITY∞ to conduct an audit of the safety processes and the underlying computerized systems. The audit included an assessment of the validation status of the pharmacovigilance software in use at the CRO.
Approach to the Qualification of IT infrastructure
As part of centralizing its IT services, a pharmaceutical manufacturer has contracted QFINITY to support the implementation of an approach for qualifying the IT infrastructure. QFINITY∞ provides coaching through client workshops to build the basic knowledge that serves as a foundation for its ongoing support.