A guide to outsourcing the internal audit function in life sciences
In the highly regulated life sciences industry, internal audits play a crucial role in ensuring compliance with various standards, regulations, and guidelines. These audits help organisations identify potential risks, assess the effectiveness of their internal controls, and implement corrective measures to maintain the integrity of their operations. However, conducting in-house internal audits can be a complex and resource-intensive task, often requiring specialised experience and expertise and a significant investment of time and resources.
Challenges life sciences companies face in conducting internal audits
Life sciences companies often face a myriad of challenges when it comes to conducting internal audits. These challenges include:
- Lack of specialised expertise: Conducting comprehensive internal audits in the life sciences industry requires a deep understanding of complex regulatory frameworks, quality management systems, and industry-specific best practises. Many life sciences companies may lack the in-house experience and expertise to effectively carry out these audits.
- Limited resources: Internal audit teams in life sciences companies are often understaffed and overburdened, making it difficult to allocate sufficient time and resources to thorough audits. Internal audits are often additional assignment to personnel who are employed for other functions. As such, internal audit responsibilities become a lower-level priority when there are scheduling conflicts with primary roles and responsibilities.
- Maintaining objectivity: Conducting internal audits within the organisation can sometimes compromise objectivity, as auditors may have personal relationships or biases that can influence the audit process. These situations can be a point of contention and result in distrust of the audit programme and deep organisational dysfunction.
- Keeping up with regulatory changes: The life sciences industry is subject to constant regulatory changes, and maintaining compliance can be a significant challenge for companies that do not have dedicated resources to stay up to date with the latest requirements. Situations arise where compliance to the requirement for conducting the audit becomes the primary focus, and results in a “check-the-box” exercise that allows the audit team to meet its deadlines, but results in a non-value added “time burglar” for the function being audited.
Click here to find out more about the power of outsourcing internal audits in life sciences
