Thermo Scientific™ GMP Startup, Calibration, IQOQ + PT (1 Temp Mapping) and Preventive Maintenance for Cold Storage Unit (New Product)

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

Overview

• Tailored for Cold storage equipment at the new equipment stage.
• Delivers comprehensive startup, qualification, and preventive maintenance support for GMP compliance.

Included Services

• Start-up: Ensures equipment is installed, connected, and fully operational.
• Calibration: Confirms accurate performance within specified limits and maintains ISO 9001 compliance.
• Installation qualification (IQ): Verifies installation site and conditions meet manufacturer requirements. Confirms equipment and accessories arrive undamaged and properly assembled.
• Operational qualification (OQ): Verifies installed equipment operates as intended according to manufacturer specifications, including key tests such as door ajar, power failure, and temperature alerts.
• Performance testing (PT): Custom test such as 1 temperature mapping to ensure user specifications are met.
• Preventive maintenance: Routine inspections to maintain installation-level performance. Includes inspection, cleanup, worn part replacement, 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-hour 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

• Seamless startup with validated documentation.
• Reliable performance and minimized downtime.