How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?
Drug Regulatory Body encourages to demonstrate that organization have effectively remediated problems by investigating to determine the problem’s scope and root causes,... Read More
Check Your Competency in Data Integrity
Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its entire product life-cycle. Over the last few years several, FDA... Read More
USFDA warning letter: USV’s multiple manufacturing units
Posted on04 Apr 2017
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In a warning letter dated 10 March 2017, FDA cites USV for issues related to sterility testing for its products and data... Read More
What is Corrective action and preventive action (CAPA)? What is it’s importance?
Corrective Action and Preventive Action (CAPA) management is the focal point of an effective quality management system. FDA, ISO, EMEA, and other... Read More