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.

Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the …

Aug 28, 2023 · In the complex landscape of FDA-regulated industries, Computer System Validation (CSV) is a critical process, ensuring that systems operate consistently and produce …

Dec 2, 2025 · Do you know your CSA from your CSV? Still battling with IQs, OQs and PQs? Need a steer on GAMP? Our guide demystifies the complex world of validation.

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 …

Mar 25, 2024 · 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 …

Oct 16, 2025 · CSV confirms and documents that a computerized system meets its intended purpose and regulatory requirements. Applies to all GxP-relevant software including ERP …

Mar 3, 2025 · Computer System Validation (CSV) ensures that systems handling regulated data perform correctly, comply with relevant standards, and safeguard patient safety. This article …

Aug 31, 2025 · Computer System Validation (CSV) is the documented process of demonstrating that a computerized system is installed, operated, and maintained in a way that consistently …