Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

The Digital Medicine Society (DiMe), through its Digital Health Measurement Collaborative Community (DATAcc), has launched a new educational resource designed to help sponsors and technology ...

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 ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...