Visiting Australia Would Have Been Nice, but …
Our client wanted an advisory regarding working with a given vendor whose headquarters is in Australia. We suggested that, instead of traveling to Australia to assess the vendor, we review the vendor’s SOPs from our office to 1) get a sense whether the vendor’s quality system is robust enough to support our client’s studies and 2) identify potential regulatory and business risks to our client inherent in the vendor’s processes.
By simply reviewing the SOPs, we were able to establish the following operational and regulatory trends:
- The vendor’s resources may be spread thin.
- There are risks associated with label translation and risk management processes.
- The vendor may not provide adequate customer support.
- The IT, software development and validation processes may not assure that the product is compliant.
- The quality infrastructure may be ineffective.
- Poor choice of SOP wording raises red flags regarding adequacy of the processes, personnel understanding of the regulations and quality of QA involvement.
For the cost of a one-day audit, with no travel expenses associated with it, our client was able to determine that the risk of engaging this vendor is too high. Based on our assessment, our client chose an alternative route which presented much less risk from both the regulatory and operational perspectives.
What is noteworthy here is that SOPs matter not only for regulatory compliance reasons (i.e., it is a requirement that the company has them), but also because they tell a story about the company’s way of operations, its understanding of regulations, weak links in the processes and commitment to quality.