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2008 - The Year of the eCTD
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Murtuza Vasowalla

What are the roles and responsibilities of the CCO?

Jan 21, 02:28 PM

The CCO’s role is getting increased attention as the ‘traffic cop’ who ensures that the organization is complying with regulations and policies. Mike Rasmussen’s response to the inquiry on the CCO’s top 3 responsibilities is right on: Policies and Procedures, Compliance Monitoring, and Investigations.

Policies and Procedures are the response to applicable laws, regulations, and internal governance mandates. Most Compliance departments address this with a manual process for document management and distribution with little or no verification of actual compliance. QUMAS provides Compliance Executives with an automated policy and procedure management solution that not only ensures a single system of record for compliance content, but also provides a verifiable means of proving compliance.

Compliance Monitoring, of course, is the proof of the pudding. It is one thing to put policies out there. It is another to prove that the required parties have read them. And yet another thing to prove that they understand and follow them. Our customers have been using our Read and Understood (R&U) capability to verifiably determine if a user has attested to a policy as R&U. This is recorded in the system for the specific version of the policies so a Back-in-Time report can be produced for auditors.

And, finally, Investigations are supported with a detailed audit trail and history that can accurately determine when and how an exception occurred so it can be remediated. Any remediation, whether it is a policy/procedure update or retraining, is in the system and is captured as a record of action taken. This provides a verifiable response that will demonstrate good governance to your stakeholders.


  1. Ericia C. Gray    Feb 12, 10:57 AM    #
 
 
 
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