Validation des systèmes informatises en pharmacie -démarche GAMP et COBIT : exemple du logiciel des adaptations posologiques ADAP SOL

Abstract

The evolution of digital technology is changing the stakes of industries. Today, computerized systems are at the center of all our activities. This work focuses on the use and validation process of computerized systems in the pharmaceutical field. Because of their impact on patient health, these systems must necessarily meet rigorous qualitative criteria. The first part provides an overview of validation in general terms, the concept of the system and its classification. It also covers the requirements and standards applicable to the validation of computerized systems. The second part details the validation strategy and the compliance approach based on risks for a system under development, which follows a life cycle from design to decommissioning and also for a computerized system in operation, including the case of our configurable software ADAP Sol (used for dosage adjustment) on which we develop the practical part. A software has been developed in house by Dr, CHELLIK and used in the laboratory of galenic pharmacy of the department of pharmacy of the faculty of medicine - Ferhat Abbas University - Setif. To proceed with the validation of ADAP Sol, 9 tests were carried out on different functions and the results of the tests show that ADAP Sol is suitable for its intended use and meets the regulatory requirements.