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Article

Title: Validation of Spectrometry Software: Applying an Integrated...

Author: McDowall, R D Article Type: Product Analysis
Source: Spectroscopy, v21 n12 p90(6) Publication Date: Dec 2006
  ISSN: 0887-6703
  Illustrations: Graphs
URL of Publication: http://www.spectroscopyonline.com

In applying an integrated approach to equipment qualification of a near-infrared (NIR) spectrometer with the validation of the controlling software, it is important to be aware of the overall process and ensure that there is no wasteful duplication of work. There is no standard rule for the integration because laboratory users have different approaches and different needs for performing different tasks. The integration process is significant in identifying raw materials in manufacturing. The first part of the qualification process involves determining user needs for the instrument and the software so as to outline the intended use of the system. The process of component installation and integration comes next. Once installed, the user needs to determine what the vendor proposes to do and critically countercheck it against the organizations requirements. Calibration is one of the main factors that the vendor could ensure. The parameters involved should include wavelength accuracy, photometric linearity, and noise. Tests should be performed either during the vendor commissioning phase or during the integrated qualification and validation step. The user then needs to define ways of working with the system. This process would involve qualifying the system according to the predetermined requirements of the organization. Calibration of the instrument as well as software and firmware configuration would also be necessary. User acceptance that the system meets the intended user requirements is the next process. Upon user acceptance, the system can be released for operational use.

Special Features: Graphs

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Near-infrared Spectroscopy

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