Apr 11, 2018 · Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing the way it …

Dec 2, 2025 · It's the process of ensuring that the digital tools used by regulated companies are safe and fit for purpose. After all, a bug or untested feature in a software system that helps treat patients …

Nov 30, 2025 · To help regulated companies understand the structure behind a compliant validation effort, this guide outlines the full step-by-step process for Computer System Validation in clear 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 considering the risks …

Welcome to this comprehensive guide on Computer Systems Validation (CSV), a critical component in the life sciences industry that ensures the reliability, accuracy, and integrity of computerized systems.

Jul 14, 2025 · Software validation is the documented process of the software lifecycle that covers all phases of software product development. This process begins with planning and requirements …

Jul 9, 2025 · Computer System Validation, or CSV, is a modern, risk-based methodology that confirms software used in pharmaceutical operations functions as intended. The risk-based approach is based …

Computer Software Validation is the process of ensuring that a software program performs its intended function consistently and reliably. This is achieved through testing and documenting all stages of …

Jan 11, 2025 · This article delves into the importance of software validation, its regulatory frameworks, and how businesses can implement robust validation processes to ensure compliance and maintain …

On September 24, 2025, the FDA published its long-awaited final guidance “ Computer Software Assurance for Production and Quality System Software ” for medical devices. The document …