"For example, the computer in [Pan's] quality unit area did not have controls to restrict access and prevent unauthorized changes to data files and folders," FDA writes. In light of these issues, FDA ...
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, ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
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