Validation Overview
AITHERAS offers a full range of validation services that can be customized to meet your company’s needs. We can provide a complete validation staff to perform all your validation work for a project, or we can provide support services to supplement your validation staff.
The following AITHERAS validation services can be provided in any combination:
- Validation Master Plan development
- Temperature Mapping Studies utilizing Kaye Instruments metrology equipment
- Turnover Package development and organization of activities typically identified as Construction Qualification
- Protocol development (IQ, OQ, and PQ) and protocol execution
- SOP development
- Final report writing
- Cleaning Validation
- Validation of computer systems, including automated or semi-automated processes, controlled by a DCS (distributed control system), PLC (programmable logic controller), or similar computer system
- Auditing experience with GMP/GLP/FDA regs for facilities equipment or calibration operations
- Calibration services
- Training programs for cGMP compliance and validation procedures
- Support for presentations to regulatory agencies including the FDA (Food & Drug Administration)
- cGMP audits
- Consulting services for regulatory affairs and current Good Manufacturing Practices (cGMPs)
- Equipment Qualification
- Process Validation