Abstract
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 quality and completeness of data associated with making drugs are, however, huge concerns at agencies such as the U.S. Food & Drug Administration. And drug companies are being forced to pay attention to data in response to a sharp increase in the number of FDA warning letters citing inadequate data integrity. Quality managers who work on improving the thoroughness and accuracy of data agree that the recent spike in warnings does not reflect a sudden problem with data integrity. It is, they say, the result of industry and regulators coming late to the realization that computer-managed data is in bad shape. Regulators, in particular, have struggled with the conversion from paper-based to electronic filing, given the difficulty of discovering
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
