Compliance Auditing and Monitoring for Life Sciences Companies
The life sciences industry is constantly being impacted by new and evolving regulatory guidelines, laws, and subsequent enforcement actions. Government regulators have made it clear that they expect life sciences companies to be proactive in addressing areas of non-compliance within their organisations. The first step in addressing non-compliance is to identify it.
As such, government bodies have mandated that life sciences, medical device, and pharmaceutical organisations have robust auditing and monitoring programmes in place.
Compliance Auditing
It is imperative that companies assess the effectiveness of their compliance programmes on an ongoing basis. The primary output of an organisation’s annual compliance needs assessment is a prioritised list of activities and functions that are exposed to varying levels of risk.
Areas identified as presenting high to moderate risk should be audited to identify breakdowns in controls that may lead to non-compliant actions. These audits can be conducted at the local/affiliate or regional level, depending on the organisation’s risk exposure. Our team supports this process in a nimble and scalable manner across the APAC region.
Audits should include, at a minimum, the following four components:
- Workplan Development
- Documentation Review
- Systems and Process Review
- Transaction Testing
Upon completion, organisations can determine whether instances of non-compliant behaviour are isolated, one‑off violations or indicative of a broader, systemic issue. This insight enables companies to implement effective corrective actions, mitigate ongoing risk, and return to a strong compliance posture.
