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 ...

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, ...

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 ...

Are you grappling with managing your test data in an automation framework? Here’s a fact: effective Test Data Management (TDM) can significantly improve your software testing process. This ...

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 ...

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 ...