Thermo Fisher Scientific TruScan RM instrument performance certification

The Contractor shall provide the Thermo Fisher Scientific TruScan RM instrument performance certification and related products and support  for 16 instruments, brand name or equal to. 

The salient functional characteristics for the Thermo Fisher Scientific TruScan RM instrument performance certification and related products and support are the following:

• The annual performance certification shall validate that the TruScan RM instruments are functioning properly,
• The annual performance certification shall still allow the instrument user the flexibility to develop methods using a third-party software program and transfer the methods to multiple TruScan RM hand held Raman instruments,
• The annual performance certification of the TruScan RM hand held Raman instruments shall allow the user to adjust the laser power and scan time during sample analysis,
• The annual performance certification shall allow the user to collect and store spectra and transfer spectra and results to a computer network or standalone computer,
• The annual performance certification shall allow for the transfer of Raman spectral data in a format that can be uploaded easily into the Eigenvector Solo+Model Exporter v8.1 software without any additional data manipulation.
• The annual performance certification shall be valid for 12-months from date of certification.

Compatibility

• The annual performance certification shall be compatible with the existing Thermo Scientific TruScan RM.
• The annual performance certification shall be compatible with the Eigenvector Solo+Model Exporter v8.1 software and shall not require any additional data manipulation.
• The annual performance certification shall be compatible with the FDA environment which consists of Microsoft Windows servers and Microsoft Exchange Servers.

NOTE: To be considered an “or Equal” solution, any alternative solution proposed shall 1) be compatible with existing TruScan and FDA environment in its entirety; 2) include any necessary technical add-ons, additions, etc. that would be required to establish a similar configuration that can be achieved with the existing Thermo Fisher instruments.

(Please Note: FDA defines “compatible” as meaning there will be no communication, performance, or maintainability issues of solutions with differing brand names.)