Testing and Thriving in an FDA Regulated Environment

As for all life-critical software, the FDA guidance document on software validation emphasizes defect prevention, complexity analysis, risk assessment, and code coverage. Additionally, all software changes must be managed carefully and tested extensively. Based on his many years of experience testing biotech products, pharmaceuticals, medical devices, and various healthcare systems, Jim Bedford discusses the practical software tools and practices he has used to meet these stringent expectations. As a first line of action, Jim recommends implementing automated coding scans to verify that development consistently follows standards and recommended best practices. Further, measuring code complexity and path analysis provides a way to quantify risk and design corresponding test plans. Change analysis tools determine the downstream impact of modifications to selected code modules, and post-testing coverage measurements document untested areas of the software. Add to your arsenal of testing practices to ensure a safe system implementation and successful navigation of challenging regulatory waters.

• How complexity analysis identifies and quantifies error-prone code
• Examples of coding standards to help prevent defects
• Automated code coverage tools to document adherence to FDA testing requirements