Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

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

Join host Neil Lander as he welcomes Katy Rhynard, Associate Director of Laboratory Informatics at Gilead Sciences. In this episode, Katy discusses the intricacies of validating chromatographic ...

We conducted a retrospective study using claims data from three Japanese institutions, including two designated cancer care hospitals (DCCHs), between April 2016 and August 2022. An algorithm that ...