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.
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:
Once executed, it can then be determined whether instances of non-compliant behavior are “one-off” violations or if there is a more systemic problem going on. This clarity allows companies to then put in place effective corrective action to curb the tide and get back on the right track.
Baker Tilly Life Sciences provides a comprehensive suite of services to address your compliance auditing needs:
Typical areas to audit include, but are not limited to, the following:
No matter how much preparation, training and documentation we do, there is still a high level of uncertainly related to the question: “Do we really know what is going on out there”? Compliance Monitoring is the most effective way to address that fear, uncertainty and doubt. Since it is performed in real time, monitoring allows you to continually assess the health of the compliance program on an ongoing basis.
Continuous monitoring can take the form of transaction/paper based monitoring as well as in-person “live” monitoring of specific activities.
Baker Tilly has independent, scalable compliance experts that help in execute on your compliance monitoring needs.
The following tasks can be completed by our team to ensure a robust monitoring program:
At Baker Tilly, our Life Sciences Consulting team supports our clients’ transactional and live monitoring needs for risk areas across the organization, including, but not limited to, the following:
Our focus on value protection means we remain engaged with our clients to support their ongoing auditing and monitoring strategies.