Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Bryan Ennis is the CEO and cofounder of Sware, a regulatory technology company serving healthcare, life sciences and SaMD companies. “The measure of intelligence is the ability to change.” This famous ...

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...