Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 37: Retrospective Validation
Published:23 Nov 2016
2016. "Retrospective Validation", Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, Robert McDowall
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Systems that are operational in regulated environments but are not validated must be brought under control and validated. This is either due to the fact that the system was not operating under a regulated environment or that the laboratory was too lazy or did not have computer validation knowledge. In the former situation it is possible to justify that the system is new to the regulated environment and a degree of prospective validation can be undertaken. In the latter case retrospective validation is the only option. Retrospective validation is expensive to perform. Depending on the age of the system it is often better to replace and validate a new version of the CDS or a completely new CDS than validate a system retrospectively, however, that will depend on the work performed and the criticality of data and information generated by the system.