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 …

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 …

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 …

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 …

The purpose of this white paper is to provide guidance for the industry on the key concepts of Computer Software Assurance and provide direction to apply rational and critical thinking and …

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 …

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

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 …

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 …

Computer software assurance (CSA) has been discussed widely in industry over the past five years. While the principles are well understood and welcomed, until now some of the practical …