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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
GCP Audit of Processes and Computerized Systems at an academic CRO
An academic CRO contracts QFINITY∞ to audit its GCP processes for compliance with regulatory requirements. The audit also included the processes and validation status of computerized systems used for data management and statistical analyses.
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.