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 ...
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, ...
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 ...
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 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 ...
The General Services Administration has listed several upcoming improvements to the entity validation process at SAM.gov. The forthcoming changes were informed by user and industry feedback and ...
General Dynamics Chairman and CEO Phebe Novakovic told investors and analysts during an earnings call last week that the company’s efforts to obtain type certification on the Gulfstream G700 in ...
Initial validation and assessment for Class 2 cargo vans has begun at AMEC facility outside Tunica, Mississippi. Company on track with Q2 2022 deliveries for fleet order customers. BREA, Calif., Dec.
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