JD Supra

Addressing Data Integrity Challenges in Medical Device Submissions

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, ...
RAPS

FDA finds data integrity problems in recent warning letters

The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
マイナビニュース

データインテグリティとは何か?

デジタル社会の現代、日々、どこかの誰かがデータを改ざんしたり、書類を偽造したり、といったことが起こっている。また、そうした意図がなくても、データ転送中のエラーでデータが破損したり、宇宙放射線などの影響で、データが書き換えられて ...
Medical Dialogues

Bird Droppings, Missing Test Data, Fraudulent Records: USFDA Flags Major Deficiencies at ...

Dabur India has come under intense regulatory scrutiny after investigators from the U.S. Food and Drug Administration (USFDA) documented a series of significant quality, data ...