There are several factors to consider when
determining the frequency of vendor audits, many related
to the relative risk of the system to patient’s safety, drug
product quality, and data integrity. One factor is the vendor’s
performance and response from previous audits. If they
performed well, re-auditing those vendors every three years
could be justified, but not longer. For other vendors that are
mission critical or perhaps those that didn’t perform well in
prior audits, re-auditing every 12 months is justified to increase
scrutiny.
