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8 Jul 2019

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, conducting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to contains Nonbinding Recommendations), and implementing a management strategy, including a global corrective action plan that addresses the root causes.

This may include retaining a third-party auditor and removing individuals responsible for data integrity lapses from positions where they can influence cGMP related or drug application data at your firm.

It also may include improvements in quality oversight, enhanced computer systems, and creation of mechanisms to prevent recurrences and address data integrity breaches (e.g., anonymous reporting system, data governance officials and guidelines).


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