Sep 13, 2022 · This draft guidance provides recommendations on computer software assurance for production or quality system software.

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 of the CSV process, …

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

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 reliability, quality, …

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 considering the risks …

Dec 5, 2025 · Once it has been determined that a software feature, function, or operation is intended for use as part of production or the quality system, a risk-based approach should be used to determine …

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 with our …

The document provides guidance for implementing Computer System Assurance (CSA) to overcome challenges with traditional computerized system validation.

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 commensurate it …

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 system and the …