The reference standards and methods used to validate the systems are those set by GAMP® 5, which follows a risk-based approach. This process increased software quality and improved maintenance. A multidisciplinary group performed a software risk assessment and control to identify the level of the risk for each software module and to carry out a series of activities and tests.
This article focuses on the software verifications of two machine models. Given the growing level of automation, validation of computerized systems must be an integral part of projects to guarantee the quality of products and process controls.
