This course introduces the concepts of Requirements, Verification and Validation as applied during system development. Students completing this course will understand the terminology, usage, planning, ...

Formal methods represent a rigorous suite of mathematical techniques designed to specify, develop and verify system models with a high degree of reliability. In system modelling, these methods provide ...

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 ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Computational models and simulations have had an important role in engineering analysis since as far back as the 1960s. It is widely recognized that the use of modeling and simulation tools can make ...

In Chapter 1, verification is defined as the process of determining how accurately a computer program (“code”) correctly solves the equations of a mathematical model. This includes code verification ...

Digital identity verification has entered a new phase. What used to rely on static rules, document uploads, and manual review ...

An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...