Review of the effectiveness of a CSV approach using a questionnaire

QFINITY∞ was commissioned by a global pharmaceutical manufacturer to challenge its CSV validation approach, which has been in place for several years, with regard to further simplifications, optimizations and improvements (framework with templates, application in projects, support of tools used). A comparison of the method with other companies was also to be carried out. For this purpose, QFINITY∞ created a comprehensive questionnaire, which is used to conduct interviews at the international level with people from different divisions and roles (business departments, IT, QA, external consultants of the customer). On the basis of the prepared results, detailed recommendations on the individual topics are proposed.