Audit Preparation

The purpose and scope of the Pharmacovigilance (PV) audit is typically determined by the sponsor; however, it is important to have an open discussion with the sponsor to determine what the objectives of the audit are. The sponsor may initially have certain objectives in mind, but once you and the sponsor discuss the upcoming audit in terms of purpose and scope, this may change. The lead auditor has the responsibility for the overall management of the audit. This individual needs to be an experienced and competent auditor but must also know how to select and manage the appropriate team members with the necessary skills to contribute to the audit. Audit team members are selected based on auditing experience and subject matter expertise but there are other characteristics that are equally important. The composition of the audit team should be aligned with the expertise needed to achieve the audit objectives and the complexity of the audit. The need for an audit plan will be determined by the audit sponsor. Not all audits require an audit plan, and the need for this document is dependent upon the sponsor’s internal audit program.