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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...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 ...
Attackers increasingly target non-production environments, where sensitive data often hides. Aaron Jensen of Delphix outlines ...
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 ...