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 ...

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, ...

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 ...

Fourteen years ago, the MHI T-Point demonstration combined-cycle plant in Takasago, Japan, changed the way modern gas turbines are validated under real operating conditions. In February, T-Point ...

AUMOVIO and Amazon Web Services (AWS) announced a strategic agreement that establishes AWS as AUMOVIO’s preferred cloud ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Vivek Yadav, an engineering manager from ...

Software testing, verification and validation form the backbone of modern software quality assurance. These interrelated activities ensure that a software system accurately implements its intended ...

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 ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

Testing an AI agent for donor tissue screening at Evergen surfaces more than technical performance questions. The project ...

One of the key stages in designing any chip is the testing you do when you get the first silicon back. This is where you finally see the results of all your careful work and determine whether the chip ...