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 ...
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 ...
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, ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...
SK hynix completed the development of the industry-leading 10-nanometer process technology-based fifth-generation DDR5 DRAM and entered a product validation process with U.S. chip giant Intel, the ...
Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...
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