Computer Software Assurance for Production and Quality …
Feb 3, 2026 · This draft guidance provides recommendations on computer software assurance for production or quality management system software.
CSV vs. CSA: What Are the Main Differences? - Scilife
Feb 12, 2026 · Computer System Validation (CSV) and Computer Software Assurance (CSA) play a key role in digitalized life sciences companies. Discover their differences!
What is computer software assurance (CSA) and why is the FDA
Sep 4, 2020 · The FDA’s new approach to CSV, Computer Software Assurance (CSA), represents a step-change in computer system validation, placing critical thinking at the center …
FDA’s 2025 Guidance on CSA: What Manufacturers Need to Know
Sep 24, 2025 · Computer Software Assurance (CSA): A risk-based approach for establishing and maintaining confidence that software used in production or quality systems is fit for its …
A Step-by-Step Guide to Computer Software Assurance (CSA
Dec 2, 2022 · Our guide provides valuable insights, testing methods, and objective evidence for production or quality system software. Stay compliant and ensure your company's success …
Scope of this document is to provide guidance and sample templates that are required for implementation of Computer Software Assurance for the benefit of the industry.
CSA (Computer System Assurance): A paradigm shift of the …
Jun 26, 2024 · Computer System Assurance (CSA) and Computer System Validation (CSV) are two approaches used in the field of software and systems development to ensure the …
Your Guide to Computer Software Assurance (CSA) - ValGenesis
Apr 20, 2023 · In the new CSA methodology, assurance needs are at the top of the paradigm, second only to critical thinking. This post explains how to identify the assurance needs of the …
FDA Final Guidance Computer Software Assurance (CSA) - NSF
Feb 3, 2026 · On 24 September 2025, FDA’s CDRH and CBER issued final guidance titled “Computer Software Assurance for Production and Quality System Software”, following the …
Computer Software Assurance and the Critical Thinking Approach
The FDA draft guidance states 1: “Computer software assurance is a risk-based approach for establishing and maintaining confidence that software is fit for its intended use.