Chris Crapo

Test automation is difficult to get right. Working under FDA regulation presents its own challenges. Combining the two is a scary proposition because the FDA requires—and will scrutinize—the validation of any test automation used. Despite this, working in a regulated environment only magnifies the value of test automation. Aware that automation is a driver of quality and consistency, the FDA welcomes automated tests as part of an audit submission. The key to success is demonstrating quality in a way that the FDA recognizes. Chris Crapo and David Nelson lay out the road map to validation of a test automation system and highlight the critical thinking, planning, and types of maintenance that form the core of any successful validation strategy. By understanding the focal points of validation, you can set your project up for regulatory success while maintaining a lean, focused execution that drives results, not paperwork.