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Case study: Global Pharmacovigilance Auditing Program

Pharmacovigilance Global PV Auditing Program

Global PV Auditing Program

One of our clients requested for Pharmacovigilance audits (over 20 audits in 2016) on a global basis – to audit their global functions, affiliates, service providers and business partners worldwide. The client used to cooperate with another auditing company for a long time, but decided to change service provider, because the resources of their partner were limited. ELC was requested to provide local auditors as they would have a better overview of local requirements and culture.

Challenges

ELC Group Solution

Local auditor sourcing

ELC created the network of auditors located in each region. For countries such as Pakistan where the political situation was not stable to travel, ELC provided a remote audit. ELC’s internal team qualified all auditors prior to the on Site visit.

Auditors’ training, assuring performance consistency

ELC created a training course, a system and a schedule for keeping all auditors up to date and to make sure all information was distributed clearly and homogenously. Whenever needed, additional training sessions were organized to clarify any doubts. Regular client-specific training sessions were conducted with each of the auditors. A fixed QC team was assigned for the review of audit reports.

Project coordination, strict timelines and budget

In addition to following the client-provided SOPs, ELC created internal SOPs and workflows for coordinating the auditors incl. a timeline for each action. This also included a CAPA plan for any raised issues. Regular TCs and written periodic reports – per client’s requirement. The back-up PM was fully involved in all project-related activities to ensure the lead PM can be filled in for at any time without handover being required.

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