Validation of industrial automation systems is the process of checking that commissioner requirements are successfully implemented. Formal approaches are needed when the considered system is critical.

The collaboration is the latest tie-up between a legacy automaker and software startup to speed up development of advanced ...

This article provides detailed analyses of Annex 11 revision and the applicable clauses of Chapter 4 that impact computerized systems.

The Verification and Validation (V&V) processes are used to determine whether the development products of a given activity conform to the requirements of that activity and whether the product ...

A complete, audit-ready Computer System Validation (CSV) portfolio project. Demonstrates the full validation lifecycle per FDA 21 CFR Part 11 and GAMP 5 for a mock clinical trial system, including URS ...

In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...

Model-based systems engineering (MBSE) is the formalized application of modeling to support system requirements, design, analysis, verification, and validation activities beginning in the conceptual ...