Computer Software Assurance for Production and Quality Management System Software Guidance for Industry and Food and Drug Administration Staff

A senior IT validation professional supports the proposed CSA guidance as a beneficial evolution but argues that it contains specific gaps regarding AI tools, decision-support analytics, and portfolio-level validated states. The commenter recommends adding specific examples to Appendix A to address these complexities, including human-in-the-loop controls for AI and cumulative change risk across integrated systems.