What does a company that has incorporated a proactive compliance program look like?
A firm with a proactive compliance program has developed a process, involving Operations, Quality, R&D and Compliance, to self-identify potential issues before there are any negative effects, assess the risk associated with the potential issues, and prioritize remediation of the issues so that the most severe are corrected first. Finally, Senior Ma-nagement is aware of any significant issues at the site, can assess and verify lower level decision making and ensure the correct prioritization and resources are available for remediation efforts.
[GMP Compliance Adviser, Chapter 1.O]
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