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 ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

When The MathWorks introduced Matlab technical-computing software more than 20 years ago, many of the first users were control-system designers. Anyone who had laboriously inverted matrices by hand to ...

Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presentation ...

From my product development experiences, entering into Design Verification and Design Validation is always bittersweet. Exciting because yes, to get to Design Verification means that we have ...

With the increased use of electronics and software in the automotive systems, there are strict requirements for complex functions to perform safely and avoid causing damages to life and property in ...

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms ...

Every product has defects. Finding them as early in the development process as possible is definitely something to strive for. Building quality into software as it's being developed is far more ...