Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems. Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for ...

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream. All sectors of ...

For a variety of reasons, software verification and validation has proven to be one of the more challenging and nebulous areas of compliance for companies regulated by FDA. Software, and how it is ...

Regulation and the pharmaceutical sector are intrinsically linked. Indeed, it’s no exaggeration to state that the global pharmaceutical sector is one of the most heavily regulated industries in the ...

Flagship consumer electronic device launches are among the most operationally complex events in modern engineering. They require years of coordination across hardware, silicon, RF, software, ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Andy Brinkmeyer shares how engineering ...

A monthly overview of things you need to know as an architect or aspiring architect. Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with ...

Verification and validation are two important steps in the creations of electronic systems and over time their roles, but how they play together is changing. In fact, today we are seeing a major ...

The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ ...