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  • IT Compliance Consulting
  • Internal IT / Vendor Audits
  • Data Center Audits
  • Part 11 Compliance Assessments
  • FDA Inspection Technical Support
  • Remediation / Mitigation Plans for Audit observations
  • Infrastructure Qualification
  • Validations
  • Protocol Development & Execution
  • Operational SOP’s development
  • Change Management / Non Conformances Investigations
  • Computerized Systems Evaluations
  • Training




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