Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

Assuring HMDA data integrity, whether manually or through systemic data integrity testing should be an integral part of the ongoing monitoring process. Beginning with the 2018 HMDA data, regulatory ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. GenAI is also making a splash in software development and mobile applications. In fact, due ...

Advanced technologies in pharma manufacturing necessitate a redefinition of the Qualified Person's role, focusing on digital ...

During the 2017 ISA Food and Pharmaceuticals Industries Division Symposium, I attended an informative presentation, Data Integrity: A Partnership of Business Processes and Technology,- by Marcus ...

As emphasis grows on managing data in pharmaceutical labs and plants—collecting and storing it, sharing it, mining it for pertinence—a basic question often goes unanswered: Is the data any good? The ...

The data connection device under test in Figure 1 is characterized by comparing test signals sent into the link with signals measured at the link output. The differences between these two test signals ...

The world is changing more rapidly than ever. With the explosion of Artificial Intelligence (AI), Machine Learning (ML) and data analytics, semiconductor manufacturers now have the opportunity to ...

The Integritest 4 Was Assessed Using Oversize Volumes to Determine Accuracy of Results Sterilizing-grade filters are designed to reproducibly remove microorganisms from the process stream producing a ...