QFINITY · News · Insights & Events
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
Review and optimization approach to the 21 CFR Part 11 capability of a planned ERP system
A manufacturer of high-performance ceramics for dentists and dental technicians planned to introduce a new ERP system. The project needed to address the new system’s 21 CFR Part 11 capability. In addition, QFINITY∞ ran a workshop to develop the recommendations to take into account regarding Part 11 in the new system.
Data Management Audit of processes and computerized systems at an academic spinoff company
An academic spinoff company contracts QFINITY∞ to audit its data management processes for compliance with regulatory requirements. The audit also included the processes and documentation concerning the underlying computerized systems, including their validation status.
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.