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 ...

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, ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

As technology capabilities and customer requirements have evolved, so have gas turbine testing and validation methods. Mitsubishi Hitachi Power Systems believes the proof of its long-term validation ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...