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 ...

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 ...

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 ...

I’ve spent the past six months leading market validation as we prepared to launch the most significant enhancement to our product yet. It was a robust and rewarding process, including one-on-one ...

Ensuring accuracy and timeliness of product validations is crucial for success in the contemporary fast-paced nature of business. The tiring plethora of validation has been altered with automation in ...

Semiconductors are the fundamental building blocks of contemporary technology, driving everything from satellites to cell phones and creating the framework for the digital era. With its rapidly ...

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 ...

Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...