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PV Auditing

European legislation requires the Marketing Authorisation Holder (MAH) to perform regular risk-based audits of their pharmacovigilance system.

The expectation is that the MAH will have a risk based approach to PV auditing and will systematically plan their audit schedules. This planning (according to the legislation) should include strategic, tactical and operational planning.

Jonathan West has conducted dozens of pharmacovigilance audits over 4 continents, and is an accomplished auditor. In addition, PhV Services can team up with other established auditors to deliver an audit program that is tailored to the client’s specific requirements.

Audit Services:

  • Strategic planning (long term strategy, outlines the areas that the audit program should cover, builds in a risk-based approach)
  • Tactical planning (one-year risk-based audit program, sets scope for each audit)
  • Operational planning, conduct of audit, and reporting:
  •  Notification to auditees
  •  Agenda preparation
  •  Pre-audit preparation
  •  On-site or remote audit
  •  Report write up
  • Audit outcomes and follow-up
  •  Route cause analysis, impact analysis, and CAPA preparation

Whatever your PV audit requirements, PhV Services can help. Please call +44 (0)1363 775981, email or click to discuss your requirements.