Audit findings typically reflect those findings you can expect in from a health authority inspection. Although the most common findings vary by GXP, within the R&D space, i.e. GCP and GVP, there are topics/findings that overlap.
Given the amount of outsourcing done by the industry, VENDOR OVERSIGHT, is a critical. The health authorities are looking to ensure that the sponsor does not abdicate responsibilities and that there is sufficient documentation to demonstrate oversight.
MONITORING is another common finding. The number of sites is often questioned and the standard answer is that the sites chosen are “risk-based”. While this sounds like the best answer, the rationale that makes the approach risk-based must be articulated. The conversations progress along this same path when discussing the audit approach, although the finding is not as common.
LATE SAFETY REPORTING, be it from a clinical trial (SAEs) or reported spontaneously (ICSRs), are an easy finding for the auditor. This topic is quantitative and has no room for interpretation.
The health authorities are reviewing and categorizing topics associated with the QUALITY
MANAGEMENT SYSTEM (QMS), more now than ever. Process and training deficiencies, historically, have been stand-alone findings; these are now being captured under the umbrella topic of the QMS. Another topic that demonstrates the interest in the QMS is REPEAT FINDINGS and the review of Effectiveness Checks for previous findings. Repeat findings are, likely, due to the Root Cause not being properly identified and addressed. Root Cause Analysis (RCA) is a posted as a separate topic.
