For years, Computer System Validation (CSV) has been the standard for ensuring digital systems perform as intended in regulated manufacturing. But for many organizations, it has also become slow, expensive, and overloaded with documentation that does little to improve patient safety or data integrity.

In this episode of Life Science Solutions, host Chris Adkins sits down with Tara Doby, PMP, Manager of Technical Services at Kymanox, to unpack the industry's much-needed transition from traditional CSV to Computer Software Assurance (CSA). Tara explains how CSA utilizes the familiar GAMP 5 risk-based methodology, but strategically reduces the burden of step-by-step scripting for low-risk systems.

If your team is still validating systems simply because “that’s how it’s always been done,” this conversation will help you rethink your approach.

Topics Include:

• The CSA Mindset Shift: Why CSA isn't necessarily "less work," but rather a strategic refocusing of attention onto areas with the highest risk to product quality and patient safety.
• Unscripted vs. Undocumented: How to leverage knowledgeable Subject Matter Experts (SMEs) for unscripted testing without falling into the trap of failing to document the testing.
• Organizational Pitfalls: Why siloing your CSV efforts into a separate department often leads to redundant work, stepping on toes, and severely overburdening your Quality Assurance (QA) team.
• The Future of Validation: The growing necessity of leaning on vendors as subject matter experts, adopting a "trust but verify" approach to vendor testing, and the critical importance of robust vendor onboarding.
• Taking the First Step: Practical advice for introducing CSA principles, starting with stakeholder conversations and avoiding the conservative trap of labeling every single item as "high risk".

This episode is designed for CSV, CQV, and QA professionals who want a clearer, more efficient approach to validation, supported by real risk based thinking.

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📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.