An Ergonomic Perspective of Software Validation in the Medical Product Manufacturing

This chapter presents the eDHR computerized system validation process (eDHR) in direct relation to the intended use of said software. This consists of electronically recording the history of medical devices that are manufactured in a company located in Tijuana. This work is referenced in the fifth version of the Good Automated Manufacturing Practice Guide 5 (GAMP5) of the International Society of Pharmaceutical Engineering (ISPE). This guide contains the implicit risk-based approach to the quality and labeling of medical devices. In addition, it is based on the regulations that companies regulated by the Food and Drug Administration (FDA) must abide by.