Thermo Scientific™ GMP Startup, Verification wrt EN12469 Std, IQOQ + Preventive Maintenance for Biosafety Cabinet (New Product)

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

Overview

• Tailored for Biosafety cabinet 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.
• Certification: In the United States, NSF 49 certification will be provided for BSC equipment, while in Europe, verification will be conducted in accordance with EN 12469 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 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 is operating as intended according to manufacturer’s specifications and complies with standards and requirements.
• Preventive maintenance: Routine inspections to ensure equipment performance is sustained. Procedures include 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 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

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