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 …

If you wonder why needs a computer system validation, how the process looks like or you need some examples, have a look at this page.

Jan 10, 2026 · Computer system validation or CSV is also called software validation. Regulated companies must prove with evidence that their software systems are performing as they are …

This review aims to provide an essential guide to computer system validation (CSV) in the pharmaceutical industry. CSV is a process for ensuring that computer-based systems produce …

Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP …

Jun 23, 2025 · At its simplest, computerized system validation definition is the documented evidence that a system consistently produces the correct results. This involves planning, …

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 …

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 …

What are the key components of the computer system validation lifecycle? The key components include thorough testing, detailed documentation, compliance with Good Practice (GXP) …

Nov 20, 2025 · Here, we’ll outline the essential best practices for computer system validation to help you build a robust, efficient, and audit-ready framework.