Implementation of a CAPA-system for clinical trials. In a biomedical technology company

      Аннотация: This book gives an insight into the quality management concept – Corrective and Preventive Actions system (CAPA-system) adapted for clinical studies in the bio-medical technology industry. The CAPA-system is one of the quality management tools that supports quality management in ensuring safety and the rights of the subjects enrolled in a study, in the process of collecting patient data and, thus, focuses on compliance with regulatory requirements and standards. The CAPA-concept is being applied when certain non-conformities or quality concerns arise. The CAPA process provides an opportunity to effectively correct existing quality problems, to ensure they do not appear again, or to prevent potential problems. Therefore, this concept is essential for an efficient business practice and continuous improvement of the company’s processes.

Ключевые слова: Clinical Trials, Implementation, Process, Proce?, Quality Assurance, Quality Management, CAPA, corrective actions, preventive actions, biomedical technology