Equipment Qualification is a validation study that establishes with confidence that the critical process equipment and ancillary systems are capable of consistently operating within established limits and tolerances. The studies must include equipment specifications and the following protocols:
- Installation Qualification (IQ) - to demonstrate that process equipment and ancillary systems are appropriately selected and correctly installed.
- Operational Qualification (OQ) - to demonstrate that process equipment and ancillary systems work correctly and operate consistently in accordance with established specifications.
- Performance Qualification (PQ) - sampling and testing at various stages on process equipment and ancillary systems to ensure equipment specifications are met.
Clevair staff are experts at creating clear and concise execution documents and summary reports. We can customize protocols to your pre-existing format or use our standard format based on industry guidelines.
Prior to execution, we verify that all applicable instrumentation on the equipment is calibrated. If the equipment is not calibrated, we can offer calibration services using the appropriate traceable standards or through a partner company.
Execution Data are collected directly on the protocol forms. Staff are trained to fill in all requested information in accordance with Good Documentation Practices. Data failing to meet acceptance criteria or producing unexpected results requires a deviation report. Deviations are addressed at the time of occurrence with direct client involvement. Our staff will provide a clear description of the deviation and recommendation for corrective action.
Post-Execution Data Review
All data are internally reviewed upon completion of field testing for adherence to the protocol acceptance criteria and Good Documentation Practices. This helps reduce the review time and streamlines the turnover process of the equipment or system from Validation to Operations, thus, helping you achieve operational efficiency.