GAMP® 5 is a guideline for the validation of automated systems in the pharmaceutical industry. The V-Model represents the development and validation process in a V-shape, with each development phase on the left side corresponding to a specific test phase on the right side. This model helps ensure that systems are thoroughly tested and regulatory standards are met. By following a sequential approach, it ensures that all documentation and validation steps are completed in a logical order. Responsibilities and accountabilities between suppliers and clients can also be defined within the V-Model. In doing so, it captures not only technical but also organizational aspects, which facilitates collaboration among the parties involved in a project.
