Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Dany Lepage discusses the architectural ...

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL. Q. We are planning to upgrade several ...

Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the importance of performing ...

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, ...

Compressed air systems are a critical component of many pharmaceutical manufacturing facilities. With any new system creation, addition, or change, a validation should be performed to ensure the ...

This course covers the key concepts of GxP computerised systems validation and compliance, including the key regulatory requirements and effective industry good practice based on GAMP®5. Computerised ...

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 ...

Silicon validation " proving the chip works correctly at speed and in system under different operating conditions " is always necessary, even for a "perfect" design. Silicon debug " finding the root ...

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...