Compliance Auditing and Monitoring
The life sciences industry is constantly being bombarded with new and evolving regulatory guidelines, laws, and subsequent enforcement actions. Government regulators have made it clear they want life sciences companies to be proactive in addressing areas of non-compliance in their organisation. The first step in addressing non-compliance is to identify it.
As such, government bodies have dictated that life sciences, medical devices, and pharmaceutical organisations need to have a robust auditing and monitoring program in place.
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 prioritised list of activities and functions which are exposed to varying levels 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. This can be done at the local/affiliate level or at a regional level depending on the risk exposure and our team can support that in a nimble way across the APAC region.
Audits should include at least the following four components:
- Workplan Development
- Documentation Review
- Systems/Process Review
- Transaction Testing
Once executed, it can then be determined whether instances of non-compliant behaviour 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.
