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Auditing
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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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