Our PV Audit Set

Our PV Audit Set is the best way for you to capitalize on the wealth of experience PV Focus has to offer. The PV Audit Set may also be used as a Mock Inspection, given that its features are based on the analysis of the current Inspection Process as implemented by the leading Regulatory Authorities in the field of Pharmacovigilance. The scope of the audit includes all processes covered during Pharmacovigilance Inspections, which can be reviewed within 3 to 5 working days at most facilities. The objectives of the PV Audit Set remain those of an audit, with the evaluation of compliance, effectiveness and the identification of areas for improvement. In addition, it offers the added benefit to prepare your organization to the inspection process.

Our PV Audit Set brings you multiple benefits, for the most cost-effective approach to your Pharmacovigilance Auditing needs:

• Minimum internal capacity needed to define the scope of the audit
• No capacity needed to establish the Audit Plan
• No capacity needed to design Audit Tools
• Consultancy costs reduced through standardized approach

>> More about The PV Audit Set Methodology
>> More about The PV Audit Set Scope
>> More about The PV Audit Set Process

The approach followed is directly based on experience of Regulatory Authorities Inspections. This includes the comprehensive review of all relevant processes in a limited amount of time. This is made possible through collection of audit information mainly during interview of relevant personnel, complemented by the review of a limited sample of documented evidence supporting the processes under evaluation. Through this approach, the key objectives are to determine if a system is in place for each process and if it is adequately and consistently implemented and documented.

The following processes could potentially be covered during a PV Audit Set, depending on their relevance to the facility audited. All the relevant processes would be reviewed for all stages of the product lifecycle (development and post-marketing):

• Responsibilities for Pharmacovigilance
• Validation of Computer Systems, Security, Back-up and Disaster Recovery
• Interaction between Drug Safety and the Medical Information Organisation
• Interaction between Drug Safety and Technical Quality Assurance Organisation
• Management of Safety related Processes in Clinical Trials
• Literature Screening
• Processing and Submission of Individual Cases
• Periodic Safety Reporting
• Signal Detection and Management
• Development Core Safety Information (Investigatorís Brochures)
• Company Core Safety Information
• Product Label / Advertising Material
• Risk Management / Pharmacovigilance Planning
• Training
• Quality Assurance

• Scope of the Audit: PV Focus will bring tools to assist in the identification of the processes to be covered, as relevant to the site(s) audited.
  


• Pre-Audit Questionnaire: Also used by some Regulatory Authorities to prepare for Pharmacovigilance Inspections, this tool is used to collect preliminary information which will be used to define the proposed agenda for the audit and to make the audit more efficient.
  


• Audit Plan: A detailed Audit Plan will be designed and provided, which describes the audit to be performed, including scope, objectives and timelines. This document may be requested during Pharmacovigilance Inspections to confirm the scope of internal Audits.
  


• Audit Agenda: A detailed Agenda will be designed to facilitate the organizational aspects of the Audit conduct.
  


• Preliminary SOP Review: PV Focus proposes this step in order to reduce the amount of time necessary at a site to review the relevant documentation, thus making the conduct of the Audit more efficient.
  


• Audit Conduct: The Audit will be conducted in accordance with the agreed Audit Plan and Agenda. The Audit Conduct will include an opening meeting where the project will be presented and a closing meeting during which preliminary audit results will be communicated.
  


• Reporting: The Audit Report will specify which topics have been covered during the Audit and a statement will be provided to describe each issue detected, together with a significance rating and a proposed action. An Executive Summary will be included. The Client will be given the opportunity to comment on the draft before the final Audit Report is released.
  


• Audit Certificate: An Audit Certificate will be provided to confirm that the Audit was conducted and whether any deviations to the Audit Plan were implemented. This document may be presented during Pharmacovigilance Inspections as evidence that internal Audits took place.