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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.
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Validation of a laboratory process in a contract research organization
QFINITY plays a key role in a project to validate a laboratory process. Our partner in this effort is a highly regarded bioanalytical contract research organization. The goal of the collaboration is to optimize highly sensitive large-molecule bioanalytical processes. This is achieved by integrating an advanced laboratory system with a sophisticated evaluation software built on Excel with VBA.
Our support covers several aspects. First, QFINITY’s experts provide the necessary standard operating procedures (SOPs) and templates to ensure the process runs in line with the highest quality standards. But that is only the beginning.
Together with the contract research organization, we go one step further. We perform a meticulous validation in which every step is carefully reviewed and documented. This close collaboration ensures that the process is not only optimized but also tailored to the customer’s specific needs and requirements.
The partnership between QFINITY and the bioanalytical contract research organization creates a team that shapes the future of this highly specialized laboratory work and ensures it meets the highest industry standards.
If you also need support optimizing your processes, you can reach us at any time via our contact form. We look forward to hearing from you.
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.