Webinar
The FDA’s final CSA guidance is here, bringing significant changes to Computer System Validation some have been preparing for since 2022. Are you ready?
Release Date
February 11, 2026
Webinar length
1 Hour
The FDA’s final guidance on Computer Software Assurance (CSA) gives life sciences teams a clearer framework for risk-based, right-sized software validation. In this on-demand webinar, Kneat Senior Product Manager Lorna Whelan breaks down what changed between the draft and final guidance, what CSA means in practice, and how to implement it. Watch to understand how CSA reshapes your approach to computer system validation.
The relationship between CSA and CSV: clarifying common misconceptions
Key changes from the draft to the final FDA CSA guidance
Scope clarification: which software is in and out of scope for CSA
Function-based risk assessment versus system-level risk classification
Testing approaches: robust scripted, limited scripted, and unscripted methods
Updated Part 11 alignment and appropriate records requirements
Practical six-step implementation roadmap for adopting CSA
How digital validation platforms support CSA execution and audit readiness
This webinar is essential for validation engineers, quality assurance managers, CSV leads, compliance officers, and IT quality professionals in pharmaceutical, biotechnology, and medical device organizations. It is especially relevant for teams currently transitioning from traditional CSV to a CSA-aligned approach, those refining existing risk-based validation strategies, or anyone responsible for maintaining regulatory compliance across production and QMS software. Leaders evaluating how digital validation platforms can reduce documentation burden while strengthening assurance will also find actionable guidance.
Senior Product Manager, Kneat Solutions
Lorna is a Chartered Chemical engineer with over 25 years in Pharma and 5 years in Medical Devices in various leadership roles, encompassing Process Engineering; MSAT, Automation Engineering; Project Management. Lorna joined Kneat as a Senior Product Owner in product development for the Lifesciences industries.
No. CSA is not a new regulation and does not replace CSV. Regulatory requirements for computerized systems validation remain in effect. CSA provides a framework that uses quality risk management to focus validation effort on the functions and features that have the greatest impact on patient safety and product quality. It improves how CSV is executed rather than eliminating it.
The final guidance adds significant clarity across several areas. It provides a clearer scope definition for which software qualifies, stronger expectations for appropriate records, improved examples including cloud-based systems, a dedicated section on Part 11 alignment, and explicit support for maintaining digital records instead of printing electronic evidence. Teams already using CSA likely will not need to overhaul their approach, but the final guidance offers better justification and examples.
CSA defines three testing styles scaled to risk. Robust scripted testing uses detailed steps with expected results for high-risk functions. Limited scripted testing provides fewer prescribed steps while remaining structured and documented. Unscripted testing allows exploratory or ad hoc approaches where the tester documents actions and outcomes without predefined scripts—appropriate for low-risk functions. The goal is right-sized testing, not reduced testing.
Begin by updating your SOPs and governance documents to reflect CSA terminology and map risk levels to test rigor. Then perform a system impact assessment to confirm scope and document intended use. Define GxP requirements, conduct functional risk assessments at the feature level, select test types matched to risk, and confirm traceability across requirements, risks, and tests. A digital validation platform with configurable templates and built-in traceability can accelerate this process significantly.
Yes. The final guidance includes additional examples relevant to cloud-based systems. It emphasizes that organizations can leverage supplier documentation—such as SOC reports and release notes—as part of their assurance activities. However, the regulated company retains responsibility for validating the software’s intended use within its own GxP environment. This applies whether the system directly supports production, quality management, or both.
A digital validation lifecycle platform supports CSA by providing standardized templates, configurable risk assessments aligned to your methodology, and automated traceability across requirements, risks, and tests. Secure electronic signatures and complete audit trails address Part 11 and Annex 11 requirements. These capabilities reduce the documentation burden that CSA aims to minimize while strengthening the assurance and compliance controls that regulators expect.
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