After the instrument is installed, the computer is installed followed by the application software. For ease of discussion, I am assuming that only one application is required. The installation of this must also be adequately documented by the vendor. If the workstation is supplied by the vendor, it might come preinstalled with the operating system, typically Windows. Alternatively, if the system is to be connected to the company network, the company IT department might supply a workstation with the appropriately configured operating system preinstalled. Regardless of the source of the workstation, it can be connected to the network and given an Internet Protocol (IP) address and other information for it to connect and store data on a network drive. Regardless of who does the work, the fact that it was done must be recorded in a compliant manner. Then the application software will be installed by the engineer; again, this will be performed and documented in a procedure that will be completed on site together with problem resolution.

When completed, the instrument and the computer system will be connected and checked out to see that the two communicate as expected by the vendor. In outline, this completes what should be done in the first two stages of the work. Most, if not all, will be performed by the vendor's engineer and will be adequately documented. It is also the laboratory's responsibility to ensure that the work is recorded in a compliant way and that the work is of a suitable scientific soundness to comply with current good manufacturing practices (GMP) regulations (4). The system owner will review this work and approve it.

Vendor Commissioning

This stage can either be a separate activity after the component installation and integration or it can be combined with them in a continuous session to make it simpler for the engineer to complete. If the latter approach is taken, the process will be from unpacking the individual components to showing that the complete system works and is acceptable from the vendor's perspective. As mentioned above, the instrument and software should work and there should be a holistic test for the overall system.

Here you should be vigilant and work smarter rather than harder. What is the vendor doing here? Are there tests that are carried out and that can be used instead of you doing the work in later stages of the process, or are there holes in the package? In this instance, you need to do more work later. Therefore, review critically what the vendor proposes to do here and cross check against the system requirements in your URS. Where the vendor's material matches your requirements, then accept this and do no further work. The problem is that you may be reviewing a standard document produced by the vendor to meet most uses of the system. Therefore, in our example of an NIR spectrometer used for qualitative work, what would your reaction be if the vendor proposed to execute tests for quantitative analysis? These tests for the way the spectrometer is intended to be used are probably as much use as a chocolate teapot.

An example that the vendor could undertake here to confirm instrument operation could be to run some of the certified or standard reference materials to demonstrate that the instrument is correctly calibrated for its intended operation. Some of the parameters include wavelength accuracy, photometric linearity, and noise. It is important that the noise of the instrument is included either here or in the user testing because the instrument performance tends to degrade over time, and therefore it is vital to monitor the overall performance.

Figure 1: NIR wavelength accuracy standard for 890–2540 nm (5,10).

If these tests are not performed here, the users should undertake them during the next phase of the integrated qualification and validation. For example, if a wavelength calibration standard used by a vendor does not offer sufficient resolution or wavelength range, then alternative sources should be used in the next phase by the laboratory. To illustrate this point, Figure 1 shows an example of a wavelength standard over the convention NIR range; more information about traceable standards in NIR will be found in an article to be published in Spectroscopy by Burgess and Hammond (5).