AI for Computer Software Assurance (CSA)

Software and related hardware design, development, verification and validation is difficult to manage, document and control, and especially so with AI implementations.

This presentation focuses on the verification and validation planning and execution of software under FDA's new CSA requirements, and after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested CSAS compliant FDA model will be evaluated, implemented, with V&V documentation and test case examples.

The focus is on the CSA Guidance on QMS/system-wide compliance and remediation approaches. 21 CFR Pt. 11, cybersecurity, ML/AI issues will be considered. Field examples, good and bad will be addressed. Evaluation of the chief areas of the FDA's new "Computer Software Assurance for Production and Quality Management System Software" Guidance Document issued on February 3, 2026, is the focus. Also how to use AI tools to facilitate compliance and documentation.

Why should you Attend: Software used in CGMP activities are under increased scrutiny by a "tougher" U.S. FDA - especially AI. The QMS, product, production / test equipment, are heavily software / firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity, and now a formal US FDA requirement. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment, demanding a product risk-based approach.

What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V and overall CSA activities are necessary to minimize software failures in the company, and meet these new FDA requirements? How can we also use AI to facilitate the documentation of CSA in the company.

Areas Covered in the Session:

• The FDA's new "Computer Software Assurance for Production and Quality Management System Software" Guidance, Feb 03, 2026
• Tougher FDA Expectations / Requirements
• Roles of Verification and Validation - and AI issues
• An FDA "Model" and IEC 62304 – medical device software
• A Typical Software V&V Protocol / Test Report
• 21 CFR Part 11, Cybersecurity, ML/AI Concerns
• AI as a Tool to Assist CSA
• Expected Regulatory Deliverables
• Complementary Guidelines, e.g., GAMP® 4 & 5

• This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, AI concerns, and the growing "cloud" environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include:
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • Engineering, R&D, and Software Development and Testing Teams
  • All Personnel involved in a U.S. FDA-regulated environment
  • Especially those involved in new product development with products and equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products activities