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  • Site and postal audits
  • Supplier / vendor / service provider audit
  • Self audit (mock inspection)

  • e-Compliance audit:
    • e-Compliance aspects of the Quality Management System (QMS)
    • Data integrity
    • IT infrastructure
    • Data management, including: backup, restore, archiving, retrieval, disaster recovery, business continuity planning
    • Electronic data archiving
    • Qualification and Validation strategies for IT systems, laboratory equipment, process control systems, MES, ERP
  • Audit of software development activities for GxP systems (project)
  • GxP compliance of Quality Management System
  • QMS related or product related audit
  • Good IT Practices related audit by service provider.


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Last update: 2020-01-25

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