Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...

General Dynamics Chairman and CEO Phebe Novakovic told investors and analysts during an earnings call last week that the company’s efforts to obtain type certification on the Gulfstream G700 in ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

Software testing, verification and validation form the backbone of modern software quality assurance. These interrelated activities ensure that a software system accurately implements its intended ...

SODA.Validate Infrastructure Solution For The First Time Brings an AWS-like Testing Process for Developing Software-Defined Vehicles. LONDON, UK, June 17, 2024 ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

One of my more aspirational career goals has been to increase the efficiency of validation testing without lowering the quality. Testing of automated systems is essential to ensure quality in both the ...

The Keysight AI Software Integrity Builder enables validation and lifecycle maintenance of AI-enabled systems to ensure ...