Molecular Spectroscopy Compliance

Take advantage of “hassle free” instrument installation in a regulated environment. Thermo Fisher Scientific can provide a turn-key solution, delivered by a compliance expert that which will significantly speed up your implementation and provide a fully validated instrument.

Get a customized end-to-end validation solution for your equipment and application (on selected instruments).  Validation services are quoted at time of instrument purchase and delivery timed with instrument installation.  In addition, you will be involved in every step of the validation process, working closely with a Thermo Fisher Scientific specialist who will customize the validation kit, execute the procedures, and develop the documentation according to your processes and the relevant regulatory requirements.  You will be involved in defining the scope as well as review and approval, and Thermo Fisher Scientific will “make it happen”.

Thermo Fisher Scientific validation experts can deliver complete service and documentation packages for compliance with a wide range of regulations, such as FDA 21 CFR:

• Part 58: GLP for Non-Clinical Laboratory Studies
• Part 210 & 211: GMP Finished Pharmaceuticals
• Part 820: Quality Systems Regulation
• Part 11: Electronic Records and Electronic Signatures
  
  

Every validation documentation package consists of the following items resulting in evidence of complete system validation:

• Validation Plan (VP)
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• Design Specification (Configuration & Infrastructure Requirements)
• Risk Assessment / Gap Analysis
• Installation Qualification (IQ) Protocol & Scripts
• Operational Qualification (OQ) Protocol & Scripts
• Performance Qualification (PQ) Protocol & Scripts
• Requirements Traceability Matrix (RTM)
• Summary Report