A critical component of regulatory compliance includes validation of testing methods, facilities, procedures, processes, software and more.
ECI-Rx 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.
- Master Validation Plans
- Medical Devices Verification and Validation
- Lab Equipment Validation
- Manufacturing Equipment Validation
- Facilities and Utilities Validation
- Product and Process Validation
- IQ/OQ/PQ Protocol Development and Execution
- Test Method Validation
- Computer System Validation (CSV)
- Cleaning Validation