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RSC Chromatography Monographs
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
By
Robert McDowall
Robert McDowall
Director, R.D.McDowall Ltd
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Hardback ISBN:
978-1-84973-662-6
PDF ISBN:
978-1-78262-407-3
EPUB ISBN:
978-1-78262-980-1
Special Collection:
2016 ebook collection
No. of Pages:
733
Publication date:
23 Nov 2016
Book Chapter
CHAPTER 11: Controlling the Validation
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Citation
2016. "Controlling the Validation", Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, Robert McDowall
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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.
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