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. Specificationss, establishing System Baseline)
- System risk analysis and functional risk analysis
- Validation and test plan creation
- System testing
- Validation and test report
- Act as project quality manager