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.
- Coordinating between the auditors, auditees, and client’s QA PV, ensuring a smooth process of the entire audit program.
- Strict timelines and budget
- Providing local auditors, incl. back up auditors, in different regions, e.g. LATAM, CIS, ASIA AFRICA, who have extensive experience in conducting PV audits and PV knowledge on both local and global requirements.
- Training the local auditors on the client’s SOPs and ensuring consistency of all auditor’s performance
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.