The review of the quality management system in pharmacovigilance by external specialists is an established procedure to verify the adequacy and effectiveness of the implementation and operation of a PV system in compliance with applicable regulations, guidelines and standards, agreements with third parties, specifications, protocols and policies, and compliance with standard operating procedures.
SwissPharmAudit® has knowledgeable auditors to perform audits and mock inspections to meet all your PV project needs.
Our PV audits cover the whole PV system (collecting, processing and submission of adverse events, project management, data management, QPPV responsibilities, writing aggregated reports, signal and risk management, PV in clinical trials, etc.).
We would be happy to support and advise you individually as part of the implementation of your audit/audit program.