cGMP Qualification Package Service
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Accelerate your new equipment's path to production while ensuring compliance with STERIS's cGMP Qualification Package Service. This comprehensive service package streamlines validation by seamlessly integrating Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and Installation/Operational Qualification (IQ/OQ). This efficient approach reduces validation complexity and risk while providing complete qualification documentation for your new STERIS equipment.
Starting with FAT at our factory, we conduct extensive testing under production-like conditions before continuing with SAT and IQ/OQ at your facility. By leveraging FAT data throughout the process, we reduce validation time and minimize on-site presence while maintaining rigorous qualification standards.
This comprehensive package includes:
Minimize operational downtime and restore your equipment’s functionality with STERIS’s Repair and Emergency Maintenance Services – available whenever you need them, with no service plan required. Whether it’s routine maintenance, urgent repairs or specialized service requests, our factory-trained technicians have the expertise and resources to deliver the services you need, when you need them.
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