In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response, and the practical applications of it all. 

The conversation also covers the evolution of software validation processes, the cost of system implementation, and the importance of critical thinking in Quality System Regulations. The impact of AI on Quality Assurance, the changing dynamics of the CSA Modern Validation, and the role of Software Assurance in the life sciences industry are also discussed.

Some of the highlights of today’s show include:

• The evolution of software validation processes, the cost of implementing a system in the life sciences industry, and the role of critical thinking in Quality System Regulations.
• FDA's draft guidance from September 2022, the industry's response, and its practical implementations
• The cultural shift and challenges that accompany the transition to CSA Modern Validation.
• The evolving relationship between life science companies and their technology vendors and how it can bring value to the organization
• The pivotal role of Computer Software Assurance (CSA) in the life sciences industry, including the unintended consequences 
• Cybersecurity and how the FDA is looking to adopt this approach across multiple agencies
• How companies can stop spending resources on testing every feature and function
• The industry's shift towards automation and data-driven processes
• The use of the word “validation” vs. “assurance”

Links:

• Medical Device International Consortium
• Case for Quality Working Groups
• FDA CSA Draft Guidance
• Etienne Nichols LinkedIn
• GG Academy
• Omnibus Bill
• Greenlight Guru

Quotes: 

“Keep in mind if you talk software validation to anyone outside of life sciences, they're going to glaze over. Validation is not used. Software validation is not used outside of this industry.”

“You could tell a lot about potential changes to a draft guidance based on the number of times you see certain things show up as a comment.”

“Now look, if everything is high risk, then you didn't do a risk assessment, just like if everything's a high priority, you haven't prioritized anything.”