White Papers for Food and Drug Administration (FDA)

Building a Culture of Compliance

IBS

This report is about understanding compliance and compliance management adequately to ensure that
your organization has the business processes and tools in place to transform compliance from a burden
to a benefit. It describes a Culture of Compliance as an integral part of the organization’s ethics and
describes the elements of compliance that are common throughout the organization. It also suggests a plan to manage and coordinate the common elements of compliance so they can produce efficiencies, maintain consistency, improve reliability and assurance, and result in increased stakeholder confidence. Finally, it identifi es the key elements of a system to coordinate compliance management, and provides an Executive Checklist to help assess your organization’s Culture of Compliance.

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