Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 11: Controlling the Validation
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. 319-332.
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The validation plan controls the whole of the validation effort. It is a roadmap for stating the tasks to be performed and identifying the personnel who are involved, what they do and what documented evidence will be produced at which stage of the system life cycle. The validation plan provides an organisation with the documented evidence of intent for a CDS validation. In addition, it can present the validation strategy for a large system with a phased roll-out or how several instances of the same software will be validated in a cost-effective manner.