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 ...

In modern integrated computer systems, assurance activities such as assessments, tests, and audits are increasingly difficult to perform in multi-party environments. But there are a few key tactics ...

Critical Manufacturing, a subsidiary of ASM Pacific Technology, and Dataworks, a provider of innovative software solutions and validation services to the life sciences sector, today announced a ...