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 ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

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 ...

Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...

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 ...