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 ...

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 ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...