cGMP Qualification Package Service

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:  

• Complete validation protocols with test results and certificates of completion for FAT, SAT and IQ/OQ
• Equipment verification printouts and test data
• Detailed calibration reports and technical documentation including specifications, schematics and spare parts recommendations
• Final cGMP Qualification Package certification