A COMPREHENSIVE ARRAY OF VALIDATION SERVICES
Here at PHC, we strive to provide you with exceptional validation services to help you meet even the most stringent regulatory requirements and performance needs. As a vertical component manufacturer, we provide turn-key solutions for validation and qualification in accordance with current GMPs, GLPs, GCPs, 21 CFR Part 11, PAT, ISO and specific customer requirements and applications.
VALIDATION FOR A VARIETY OF PRODUCTS:
With PHC as your partner, we can assist you through the entire equipment selection and testing process. We help match the appropriate equipment to your requirements (DQ), as well as arrange inside delivery and setup (commissioning) of the equipment.
- Ultra-Low Temperature Freezers (-86ºC)
- Cryogenic Freezers (-150°C)
- Biomedical Freezers (-30°C)
- Pharmaceutical Refrigerators
- Environmental Test Chambers
- Temperature Mapping
- IQ/OQ/PQ* - Installation Qualification-Verifies and documents equipment installation to be compliant with manufacturer’s requirements and specifications; Operation Qualification-Verifies and documents the full functional operation of the installed equipment; Performance Qualification
FACTORY ACCEPTANCE TESTING (FAT)
- Verification of machine assembly
- Inspection for damage and defects
- Verification of options and accessories
- Operational verification of machine
- Control verification
- Temperature performance testing
*PHC Corporation of North America executes temperature mapping during unit Performance Qualification (PQ) separate from IQ and OQ as services often involve customer specific or customized requirements that may differ from industry standards.
- Verification using NIST certified calibrated equipment
- “As Found” and “As Left” data capture for traceability
- Calibration reports
- Equipment certifications
- System calibration certification
- Verification using calibrated equipment
- Stability Testing
- Performance reports
PHC sells unit specific validation protocols, assigned to traceable standards, for those customers who prefer to execute their own validation activities or work with a local service provider. Documents numbering follows the unit serial numbers as well as customer location. Documents are generated electronically, but supplied to the customer in hard copy form to eliminate problems stemming from “uncontrolled” documentation.