Software testing, verification and validation form the backbone of modern software quality assurance. These interrelated activities ensure that a software system accurately implements its intended ...

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry. In the two years since the publication of FDA's final process validation guidance, how has this new ...

Following the recent global financial crisis, regulators have recognized the importance of stress testing, in part due to the impact of model risk, and have implemented supervisory requirements in ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

One of my more aspirational career goals has been to increase the efficiency of validation testing without lowering the quality. Testing of automated systems is essential to ensure quality in both the ...

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a ...

This issue of The Journal of Risk Model Validation features two papers that directly address validation using machine learning. Whether their findings imply we will all (including the editor) become ...

In a significant move aimed at upholding ethical standards in the realm of medical research, the Indian Council of Medical Research (ICMR) has recently released detailed guidelines on the ethical ...

Figure 1. (click to enlarge) Effect of temperature on seal strength. The green bars represent samples created using low temperature. The orange indicates packages created using the high-temperature ...