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
Auditing of the GVP processes and the underlying computer-aided systems at a pharmaceutical manufacturer
A pharmaceutical manufacturer hires QFINITY∞ to conduct a routine audit of the pharmacovigilance system to verify compliance with regulatory requirements. The audit also includes the relevant computerized systems that influence processes in the pharmacovigilance area, as well as the special role of a qualified person in the company.
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.