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

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

Among the first decisions to be made when initiating a composites testing program is the selection of test methods to follow. Unless performing highly customized testing, it’s usually not difficult to ...

New research paper titled “Supervised Learning for Coverage-Directed Test Selection in Simulation-Based Verification” from researchers at University of Bristol and Infineon Technologies. “Constrained ...

A Standard Test Method is a conclusive procedure that yields a test result. So as to achieve accurate and relevant test results, a standard test method is definite, unambiguous, and experimentally ...

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 ...

The first seven posts of my series of dealing with too many parameters expected in Java methods focused on alternative approaches to reduce the number of parameters a method or constructor expects. In ...

To test complex devices, test engineers must rely on the vector sets generated by verification engineers. Unfortunately, verification engineers—who work in a software simulation environment—often have ...

In the current series of posts I am writing on reducing the number of parameters required to call Java methods and constructors, I have focused so far on approaches that directly affect the parameters ...

As high-speed serial data rates advance beyond 50 Gb/s, conventional logic-emulating non-return-to-zero (NRZ) signaling is being replaced by PAM4, a four-level pulse amplitude-modulation scheme. PAM4 ...