Software supports manufacturing, quality systems, data integrity, and product lifecycle management across regulated industries. However, many organizations continue to apply legacy validation approaches that may not fully align with evolving FDA expectations.

This webinar examines FDA’s current position on software validation, including the shift toward a risk-based Computer Software Assurance (CSA) framework. It explores how intended use, system risk, and patient safety considerations influence validation strategy.

Participants will review practical considerations for validating COTS software, custom applications, automated production systems, and cloud-based platforms. The session discusses documentation expectations, verification and validation principles, and how to demonstrate control during inspection.

After this webinar attendees will be able to answer—

• What has changed in FDA expectations for software validation under the risk-based Computer Software Assurance (CSA) approach?
• Are current validation practices aligned with modern FDA guidance or based on legacy documentation models?
• How should cloud-based, automated, and interconnected systems be evaluated from a validation standpoint?
• What level of testing and documentation is appropriate based on intended use and risk?
• How can validation activities be structured to withstand regulatory inspection without unnecessary over-documentation?

This webinar benefits the following agencies:

• FDA-regulated medical device manufacturers
• Pharmaceutical and biotech companies
• Contract manufacturers and testing laboratories
• Organizations operating validated quality and manufacturing systems

Who should attend?

• Quality Assurance and Quality Engineering professionals
• Regulatory Affairs specialists
• Software Validation and CSV teams
• R&D and Engineering leadership
• Production and Operations managers
• Compliance and Audit professionals