Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 27: Defining Electronic Records and Raw Data for a CDS
Published:23 Nov 2016
2016. "Defining Electronic Records and Raw Data for a CDS", Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, Robert McDowall
Download citation file:
What are the electronic records or raw data generated and maintained in a chromatography data system? Why do we need to change our approach to managing electronic records compared with paper ones? The discussion in this chapter focuses on the definition of electronic records and raw data produced by a CDS that is directly influenced by the way you use the system, which of course you have defined in the URS and configuration specification for the system. In this chapter, we look at the ways to define what raw data / complete data / electronic records are for a CDS and pose the question if it is still possible to define paper printouts as raw data for a CDS.