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 ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global enterprises operating under the scrutiny of the FDA, EMA, and other regulatory ...

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 ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...