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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.
Latest articles
Validation approach for statistical software
For a customer, QFINITY∞ developed a strategy to bring SAS installations into compliance, including a generic approach for validating study-specific and cross-study programs.
Introduction of a DMS with a medical manufacturer
QFINITY∞ supports a medium-sized enterprise with requirements analysis, supplier selection, and implementation (including prospective validation) of a document management system (DMS) in accordance with the requirements of 21 CFR Part 820, ISO 13485 and 21 CFR Part 11.
Clinical studies in medical technology
QFINITY∞ supports major manufacturers of medical technology in validating a clinical trial management system (CTMS), including the connection to statistical software.