The Audit Report is the official outcome document of an audit. It summarises the observations, assesses the conformity of the processes examined, and classifies deviations (findings) by severity – usually in categories such as ‘Critical’, ‘Major’ or ‘Minor’. This report is a confidential quality assurance document and serves as objective evidence of compliance to management and to the authorities.
A precise Audit Report is the indispensable basis for the CAPA process (Corrective and Preventive Actions). Where deficiencies are identified, corrective actions to resolve the problem and preventive actions to avoid recurrence must be defined afterwards. CROs must demonstrate during regulatory inspections that an active and functioning Quality Management System (QMS) is in place that consistently works through these reports.
In regulatory practice (e.g. FDA or EMA inspections), Audit Reports are often used as evidence of ‘Sponsor Oversight’. They document that the sponsor has met its responsibility to oversee the trial. A transparent report strengthens the authorities’ confidence in the integrity of the trial data and the safety of participants.
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