Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 9: Working Electronically and Using Electronic Signatures
Published:23 Nov 2016
2016. "Working Electronically and Using Electronic Signatures", Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, Robert McDowall
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Although not an apparent part of computer validation, process mapping and analysis is a vital first step in defining the requirements of a CDS or any computerised system. Simplification or optimisation of the laboratory process will enable a more efficient implementation of a new CDS or an upgraded application where electronic signatures will be used. Moreover, identification of calculations performed in spreadsheets and their elimination in an electronic process by incorporating them in the CDS will improve the overall efficiency of chromatographic analysis in an organisation. In this chapter we will discuss the ways that the design of electronic signatures can be implemented in a CDS. Therefore, it is important before embarking on implementing electronic signatures that the software is technically compliant with the requirements of the regulation and the laboratory’s interpretation of the regulation.