This guidance provides recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system for …

Apr 9, 2025 · Computer System Validation (CSV) and Computer Software Assurance (CSA) play a key role in digitalized life sciences companies. Discover their differences!

The FDA draft guidance states 1: “Computer software assurance is a risk-based approach for establishing and maintaining confidence that software is fit for its intended use.

Dec 16, 2025 · The guidance describes “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, and identifies …

Outlined in the agency’s guidance on Computer Software Assurance for Production and Quality System Software, CSA describes a risk-based approach to validating and maintaining …

Sep 25, 2025 · Computer software assurance is a risk-based approach to software validation. This method of software validation encourages medical device companies to start by …

From critical infrastructure to everyday business operations, the assurance of computer systems' reliability, security, and compliance is paramount. This white paper explores the concept of …

Mar 18, 2025 · Computer Software Assurance (CSA) is a modern, risk-based approach to validating computerized systems that focuses on critical thinking and patient safety rather than …

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 …

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 …