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
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
A manufacturer of high-performance ceramics for dentists and dental technicians planned to introduce a new ERP system and needed to take the new system’s 21 CFR Part 11 capability into account. QFINITY∞ also ran a workshop to work out the recommendations to consider for Part 11 in the new system.
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.