Our Field Service Validation Engineers will enhance uniformity to ensure all equipment is performing to optimum levels. All data acquisition systems used by our Field Service Validation Engineers are fully configurable to the customers’ requirements, conforming with 21 CFR Part 11 and ensure data integrity throughout the validation process.
Our standard templates or custom documentation allows us to generate comprehensive validation protocols that will demonstrate compliance to both ICH/MHRA guidelines and FDA requirements. Every aspect of validation and calibration can be undertaken, including:
- URS (User Requirements Specifications)
- FDS (Functional Design Specification)
- FAT (Factory Acceptance Test)
- IQ (Installation Qualification)
- OQ (operational Qualification)
- CQ (Calibration Qualification)
- PQ (performance Qualification)