Article 17: Audit

1.   The national competent authorities and the Agency shall perform risk-based audits of the quality system at regular intervals according to a common methodology to ensure that it complies with the requirements set out in Articles Articles 8, 14, 15 and 16 and to determine its effectiveness. The audits shall cover a defined period and verify the conformity of relevant pharmacovigilance activities concerned by the audit with the policies, processes and procedures of the quality system.

2.   Corrective action, including a follow-up audit of deficiencies, shall be taken where necessary. The audit report shall be sent to the management responsible for the matters audited. The dates and results of audits and follow-up audits shall be documented.