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

This article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing ...

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 ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Martin Kleppmann, an associate professor at ...

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 ...

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, ...

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 ...

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 ...

The amount of data coming at us or that we produce ourselves in our daily lives continues to grow exponentially. It’s become the norm to stream movies and TV series from Netflix, as well as upload our ...

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 ...