Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

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 ...

These methods hold out a small amount of training data, called validation data, and use it to assess the accuracy of the predictor. To find the root of the problem, they conducted a thorough analysis ...