The objectives of any Pharmacovigilance Audit include the evaluation of the arrangements in place to meet the regulatory requirements applicable to Pharmacovigilance Systems. Furthermore, the audit will verify whether these arrangements are adequately and consistently implemented, and that appropriate documentation is available to support this.
In order to reach these objectives, PV Focus has developed a process oriented approach which is greatly influenced by actual MHRA inspection experience. It however also considers requirements of other inspectorates such as the FDA, AFSSAPS, etc... and always takes into account the applicable local regulatory requirements.
As a Service Provider, PV Focus can adapt to a variety of situations in order to meet the expectations of its clients. While some clients prefer for contract auditors to use the company SOPs and associated tools, PV Focus can also provide its own document templates.