Thermo Scientific™ GMP Startup, Calibration, IQOQ+PT (cycle test), Preventive Maintenance for Plus Centrifuge (New Product)

GMP Service Plan - New Product (NP) (Part of the Regulatory Assurance Plans)

Overview

• Tailored for centrifuge plus models (Ultra/Superspeed) at the new equipment stage.
• Delivers comprehensive startup, qualification, and preventive maintenance support for GMP compliance.

Included Services

• Start-up: Helps ensure that your new equipment is installed, connected, and fully operational.
• Calibration: Periodic verification confirms that equipment and monitoring sensors produce accurate results within specified limits. This service maintains compliance with ISO 9001 standards.
• Installation qualification (IQ): Documented verification that the equipment installation site and environment meet the manufacturer’s specifications and user requirements. IQ verifies that the equipment, manuals, supplies, and any other accessories arrived undamaged and are properly assembled and installed. Configuration details for each system component are recorded.
• Operational qualification (OQ): Documented verification that the equipment (as installed) is operating as intended according to manufacturer’s specifications. OQ verifies important equipment functions and ensures that the equipment operates as expected by the manufacturer, and that it conforms to standards and requirements. Key tests include door ajar, power failure, and temperature alerts.
• Performance testing (PT): Custom tests to help ensure that the equipment meets user specifications like cycle testing (CT) for centrifuges.
• Preventive maintenance: Routine inspections using standard procedures to ensure equipment performance is at or near the same level achieved at installation. Typical procedures include general inspection and cleanup, replacement of worn parts, performance testing, and tuning.

Additional Benefits

• Priority enhanced support commitment (Next business day) in select locations
• All-inclusive repair warranty and coverage, including spare parts.
• Dedicated account coordinator for personalized support.
• 1 hr. consultation for compliance and service support guidance.
• Unlimited E-learning access.
• 50% discount on remote monitoring solutions and optional add-ons (temp map/requalification)

Customer Outcomes

• Reliable performance and minimized downtime