Event Recap: Key Insights on CSA Adoption and Regulatory Expectations

Last week, we hosted an insightful session on Computer Software Assurance (CSA), featuring expert perspectives on overcoming barriers to adoption and maximizing its benefits. With over 50 attendees, the discussion provided valuable takeaways on how CSA can drive efficiency and compliance while addressing common misconceptions about software validation.

Key Takeaways

Our expert panelist shared essential insights into CSA’s purpose and implementation—here are some notable highlights from the discussion:

“When we discussed adopting new technologies, the number one barrier was computer systems validation. This was never the intent.”
– Francisco Vincenty, FDA

“CSA is a reminder from the FDA on what systems validation was supposed to be all along. [...] to focus on what matters and stop wasting time and resources on what doesn’t.”
– Paul Labas

“Correctly understood and implemented, CSA brings substantial benefits to both Quality Assurance and business efficiency, thus making it an exceptionally attractive proposition.”
– Paul Labas

"We decreased the number of production issues by ~50%, and reduced overall time and cost of projects by ~35%."
– Paul Labas

Industry Challenges and the Path Forward

A recent ISPE-SQA analysis revealed that over 80% of companies see internal knowledge gaps as a major hurdle to CSA adoption, with 50% unsure about regulatory expectations. This highlights a critical need for education and clear guidance in the industry.

If you’d like to further discuss CSA adoption, address knowledge gaps within your organization, or gain clarity on regulatory requirements, we’re here to help. Feel free to schedule a follow-up discussion to explore your specific needs.

For those who couldn’t attend live, you can access the full session recording here. Stay tuned for more insights and discussions on CSA and other key regulatory topics!