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, ...

On Thursday Gov. Reynolds announced the State Hygienic Lab completed the test validation process on May 13. She said it achieved high ratings of 95 percent accuracy for determining positives and 99.7 ...

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 ...

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 ...

VP and CISO for Mandiant, helping guide the company's product and solutions strategy and host of the Cyber Security Effectiveness Podcast. Understanding the effectiveness of your company's security ...

We used diabetic retinopathy (DR) as a case study to show application of the proposed biomarker development process. Loss or impairment of vision due to DR is one of the most profound complications of ...

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 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 ...

As semiconductor devices continue to advance, the demand for reliable, high-performance test sockets has never been greater. Yet, traditional socket design validation methods—such as per-pin ...