Developing the Audit Report

The development of the audit report is the culmination of all of your hard work during the audit. The approach to the audit report development varies based on the sponsor and can range from a full narrative of each topic discussed during audit, narrative of targeted sections, or an abbreviated format that includes an executive summary and the identified observations. It is important that the auditor remember who the audit report audience will be. In many instances, the sponsor will have the internal Pharmacovigilance (PV) team subject matter experts (SMEs) review the audit report, but in some instances, the audit report will be reviewed by non-PV individuals. In either instance, it is vitally important that the report is concise, clear, and well organized. The determination of the report format will dictate what information can be added to the report as well as the detail associated with each topic. The audit sponsor may request their audit report template be used or, in some instances, will defer to the auditor to use an acceptable format. It is important to discuss with the sponsor during the planning phase of the audit the requirements associated with the audit report.