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What is driving the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI. They cover 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.