Transition from CSV to CSA; FDA Final CSA Guidance, September 2025 for Medical Device Manufacturing & Quality Testing

Overview:

For decades, life-science teams have relied on Computer System Validation (CSV)—shaped by FDA’s General Principles of Software Validation (2002) and reinforced by 21 CFR Part 11—to ensure electronic records/signatures, data integrity, and compliant systems. That legacy emphasized documented lifecycle controls and evidence heavy testing.

In September 2022, FDA introduced a draft concept called Computer Software Assurance (CSA) to modernize assurance for non-product software used in production and quality systems (e.g., manufacturing, QMS tools). CSA promoted a risk-based, least-burdensome approach that focuses effort where it most affects product quality and patient safety.

In September 2025, FDA finalized CSA—and clarified its scope: software used in medical-device production and quality-system activities. The final guidance emphasizes critical thinking, proportional testing (including unscripted/verifications where appropriate), and right-sized documentation; it also supersedes Section 6 of the 2002 Software Validation guidance for this domain. Practically, that means you can reduce low-value testing and concentrate on risk, while maintaining inspection-ready rationale and evidence.

Outside the device-production/quality-system scope, many organizations are evaluating how CSA principles can inform broader GxP practice—provided the rationale is documented and reconciled with Part 11 and data-integrity expectations (e.g., ALCOA/ALCOA+) within the company QMS. Industry frameworks like GAMP®5 (2nd Ed., 2022) align with this risk-based direction, reinforcing critical thinking and scalable controls across diverse systems.

This webinar explains the transition from CSV to CSA, then walks through a step-by-step path you can adapt in your environment—decisions to make, artifacts to retain, pitfalls to avoid—and illustrates the approach with a LabWare LIMS example. A live Q&A will help you map the concepts to your systems, roles, and constraints.

Areas covered in the session:

• Understand current regulatory trends in industry for compliance and enforcement
• Understand how to determine whether a computer system requires validation and is “GxP.”
• Understand the true validation principles, first set forth in 1983 & last updated in 2002
• Learn about a strategic approach to performing validation consistently across systems in the enterprise
• Learn step-by-step how to transition your validation program from CSV to CSA
• Learn about the changes in GAMP®5, 2nd Edition vs. the original GAMP®5, & alignment with CSA
• Understand the best practices for planning a validation effort
• Learn about validation testing and how CSA can provide an easier pathway, particularly for lower-risk requirements that may be subjected to verification vs. traditional scripted testing
• Understand the documentation that remains required by FDA, particularly change control
• Learn the concepts about 21 CFR Part 11 compliance for electronic records and electronic signatures
• Understand the concepts of data integrity as expressed in the “ALCOA+” principles
• We’ll cover industry best practices to ensure the transition is smooth
• Q&A

Why should you attend?

If you’re being asked to “do more with less” in validation, this session shows how to shift from document-heavy CSV to risk-based CSA thinking without overstepping FDA expectations. You’ll see where CSA is formally in-scope (device production/quality activities) and how to translate its principles responsibly across your GxP landscape alongside Part 11, data integrity, and QMS.

You’ll leave with a clear transition path—the decisions to make, evidence to keep, and common pitfalls to avoid—so your program is consistent, defensible, and right-sized. We’ll connect the dots with GAMP®5 (2nd Ed.) alignment, smarter testing (e.g., verification vs. heavy scripting for lower risk), and the documentation FDA still expects (like change control).

Finally, we’ll ground the concepts with a LabWare LIMS example and a live Q&A, helping you map the approach to your own systems, roles, and constraints—so you can improve compliance and efficiency without overpromising scope or results.

Industries benefit from this training:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Medical Device manufacturing & quality testing operations
• The guidance for CSA can also be applied in a limited context to these industries:
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)

Who will benefit?

Personnel in the following roles will benefit:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts and Managers
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data & Clinical Trial Professionals
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in internal inspection, as well as external auditors

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. It will also help those in software development companies who support the life science industries.