Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 25: IT Support for a CDS
Published:23 Nov 2016
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 513-531.
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Networked CDS systems will require IT support and maintenance that will need to be formalised in an agreement or service level agreement (SLA) to comply with the regulations. The IT group will also need to work in a compliant manner (e.g. GXP awareness training, written procedures with evidence that they have been followed) or the effort to validate the CDS application will be wasted. The increased emphasis on data integrity means that IT should administer the system, e.g. user account management (covered in Chapter 30) and application configuration settings.