Back to the Basics of CSV Ep.3: The Future of Validation: CSA, Critical Thinking, and AI-Enhanced Assurance

Validation is evolving from a document-heavy compliance activity to a thinking-based assurance discipline.
This session explores how FDA’s Computer Software Assurance (CSA) and AI technologies are reshaping CSV, enabling faster, smarter, and more effective assurance.

Participants will:
Explain FDA’s CSA framework and its alignment with GAMP 5 principles.
Apply critical thinking to validation decisions and testing priorities.
Recognize appropriate AI and automation use in validation activities.
Design validation processes that are efficient, risk-based, and inspection-ready.
Strengthen cross-functional collaboration through shared accountability.

Key Takeaways
CSA encourages efficiency through focused assurance and critical thinking.
AI and automation can strengthen compliance - when governed and reviewed by qualified personnel.
Future validation will depend on how effectively teams align people, process, and technology.