A critical component of regulatory compliance includes validation of testing methods, facilities, procedures, processes, software and more.
CRx assures proper validation performed at appropriate points along the project timeline to ensure compliance, pass audit inspections and ultimately to maintain time-to-market objectives.
- Manufacturing Equipment Validation
- Devices Verification and Validation
- IQ/OQ/PQ Protocol Development and Execution
- Test Method Validation
- Computer System Validation (CSV)
- Facilities and Utilities Validation
- Cleaning Validation