Audit inspection readiness services

Whether you outsource any, all or none of your pharmacovigilance, you are still held responsible when it comes to regulatory audits. Regulatory audits are stressful, particularly when you are not sure what you need or where to begin. Ashfield Pharmacovigilance’s 14 years of experience and unique expertise allows us to ensure that you are fully prepared for a regulatory inspection.

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Inspection readiness considerations include:

  • Pre-inspection planning and training

  • Adequacy of pharmacovigilance process and procedures

  • Quality Management System (QMS)

  • Compliance and quality oversight program

  • Document control, record management and record retention processes

  • Audit program

  • Training program

  • CAPA and deviation management

  • Quality review processes (QC/QA)

  • Metrics to measure performance of QMS and quality objectives

  • Regulatory intelligence and knowledge management

  • IT process and computer system validation

  • REMS program and PSMF process

  • Regulatory agreements including waivers

  • Contractual agreements with partners, affiliates and vendors

  • Current product list and information

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