Compliance Auditing & Monitoring
Baker Tilly life sciences helps its clients address identified areas of risk across the organization through the design and execution of robust auditing and monitoring programs
Compliance Auditing & Monitoring
Government regulators have made it clear they want life sciences companies to be proactive in addressing areas of non-compliance in their organization. The first step in addressing non-compliance is to identify it.
As such, government bodies have dictated that life sciences, medical device and pharmaceutical organizations need to have a robust auditing and monitoring program in place.
The life sciences industry is constantly being bombarded with new and evolving regulatory guidelines, laws and subsequent enforcement actions. It is imperative that companies remain current on their legal and regulatory obligations and proactively address these areas of risk ahead of any government investigation or action.
Compliance Auditing
It is imperative that companies assess the health of their compliance program on an ongoing basis. The primary output of your company’s annual compliance needs assessment is the prioritized list of activities and functions which are exposed to varying level of risk.
Areas falling into the high to moderate level of risk need to be audited to expose the breakdown in controls which lead to non-compliant actions.
Audits should include at least the following four components:
- Workplan Development
What is the scope and objectives of the audit? How should the audit be rolled out to ensure effectiveness without impeding upon daily business operations? What are the detailed tasks needed to complete the audit? What are the roles, responsibilities and deadlines of the team? What sampling methodology will be used for transaction testing? How will we ensure a risk based approach? - Documentation Review
Do you have the right governance documentation in place? Is it complete?
