Audit and Inspection Readiness

Our subject-matter experts prepare you for regulatory audits and inspections through our specialized readiness solution.

Audit and Inspection Readiness

Our subject-matter experts prepare you for regulatory audits and inspections through our specialized readiness solution.

Findings in regulatory Audits and Inspections can lead to punitive and costly implications for organizations. Our team of regulatory experts assist PV organizations be prepared by conducting preparatory exercises, reviews and dry runs.

Our Audit and Inspection readiness solutions include:

Mock Regulatory Agency Inspections and System Audits:

  • Preparing a document staging area (War Room)
  • Prepare staff for inspection with interview training and role play
  • Conduct a Gap Analysis of all systems and departments
  • Identify deficiencies and areas of concern
  • Recommend and prioritize remediation and CAPA

Inspection Readiness:

  • Identify potential areas and organize documents relevant to the regulatory authority
  • Review SOPs to check compliance with regulations – advise updates/ CAPAs
  • Review processes to check compliance with SOPs – advise updates/ CAPAs
  • Prepare compliance reports, summaries and tables
  • Review ongoing and closed CAPAs
  • Review Pharmacovigilance System Master File
  • Prepare Presentations for inspections