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 of the effectiveness of a CSV approach using a questionnaire
A global pharmaceutical manufacturer commissioned QFINITY∞ to challenge its CSV approach, which has been in place for several years, and identify further simplifications, optimizations, and improvements (framework with templates, application in projects, support of tools used). The engagement also included comparing the approach with other companies. To do this, QFINITY∞ created a comprehensive questionnaire and uses it to conduct international interviews with people from different divisions and roles (business departments, IT, QA, the customer’s external consultants). Based on the consolidated results, QFINITY∞ proposes detailed recommendations on the individual topics.
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.