Quality Management

The service includes but is not limited to:


  • Assistance and advice in implementing Quality Management Systems for computerized systems
  • Review of company policies and SOPs
  • Establishing and reviewing CAPAs
  • Validation of computerized system (CSV)
    • System specifications (USR, FS, DS, Tech. Specifications, establishing System Baseline)
    • System risk analysis and functional risk analysis
    • Validation and test plan creation
    • System testing
    • Validation and test report creation
  • Act as project quality manager and validation lead

 

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