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Feb 12 2026, 16:00 GMT
1 Hour
Navigating the FDA's current CSA guidance: A global perspective for production and quality systems
Explore the regulatory transition from CSV (Computer System Validation) to CSA (Computer Software Assurance) following the US FDA's current guidance on Computer Software Assurance for Production and Quality System Software. Discover risk-based approaches that streamline compliance while ensuring product quality and data integrity across cloud platforms, and digital technologies, while applying these principles alongside other US and EU regulatory frameworks.
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Key takeaways:
- Exploration of the history and evolution from CSV to CSA.
- Discussion of the CSA model of validation and its implications.
- The alignment between CSA and other validation methodologies such as GAMP 5 2nd Edition.
- Discussion and suggestions regarding how to use the CSA process to build validation documents.
- How AI can be leveraged as a tool for CSA validation.
- How Ideagen CompliancePath employs CSA to reduce the documentation burden and accelerate innovation, while maintaining the highest standards for product quality, data integrity and regulatory compliance.
This session will describe how Ideagen CompliancePath can assist life sciences and regulated manufacturing organizations with adopting Computer Software Assurance within their FDA regulated operations. Whether you're managing AI/ML implementations, migrating to cloud platforms, maintaining legacy production systems, or navigating digital transformation across multiple regulatory jurisdictions, discover how CSA’s risk-based approach can help your team achieve robust validation without compromising compliance or product quality.
About this webinar:
Traditional CSV methods were built for a different era, and struggle to keep pace with today’s regulatory expectations in an era of advancing technologies. This is especially relevant when looking to leverage Digital Validation Tools (DVT) or AI to validate cloud applications and modern production technologies. For FDA regulated environments, Computer Software Assurance (CSA) changes this by introducing a modern, risk-based framework that supports emerging technologies while reducing unnecessary documentation.
Join us for an essential session where we'll explore how FDA's CSA guidance reshapes validation for production and quality system software, focusing assurance where it matters most for product quality and data integrity, while significantly reducing the documentation burden for FDA regulated environments.
We'll discuss how CSA accelerates your validation workflows through intended use definition, critical thinking-based risk assessment and leveraging supplier documentation, while maintaining full compliance within FDA regulated environments. Every validation decision is grounded in a defensible, risk-based rationale that regulators recognize, helping you harness the efficiency of best validation practices without compromising the rigor needed for product quality and patient safety.
Meet our speakers
John Howley
Principal Advisory Consultant, Ideagen CompliancePathThrough 25+ years in the IT industry, John’s career has progressed from support, to QA and on to the validation realm. Prior to Ideagen, John and a business partner launched a validation services company which supported site validation, change management, audit management and QMS administration, among other tasks. He is currently a Principal Advisory Consultant at Ideagen, providing validation services for Ideagen products and external customer systems.
Tracey Small
Principal Advisory Consultant, Ideagen CompliancePathTracy brings over a decade of experience in the life sciences sector, following more than seven years in the environmental field working in wet chemistry laboratories. Transitioning into life sciences, Tracy specialized in equipment and environmental qualification, including freezers and controlled rooms. This expertise expanded into validation, change management, vendor audits and administration of QMS and SDLC processes. Currently, Tracy serves as a Principal Advisory Consultant at Ideagen, delivering validation services for external customer systems and ensuring compliance across diverse regulated environments.
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