QFINITY · Updates
The latest from QFINITY and the field.
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
At a glance
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
Review and streamlining of IT SOPs at a pharma company
Pharmaceutical company commissions QFINITY∞ to significantly “slim down” the IT-SOP landscape. This means reducing the documents in both number and scope without jeopardizing regulatory resilience.
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.