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RSC Chromatography Monographs
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Director, R.D.McDowall Ltd
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23 Nov 2016
CHAPTER 33: Periodic Review of the CDS
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. 628-656.
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To ensure that the system remains in a validated state and under control, independent audits or periodic reviews of the CDS should be conducted on a regular basis according to a schedule that depends on the criticality of the data system. Observations by the audit team will be noted and the process owner will be responsible for correcting any periodic review findings. Data integrity audits, as suggested by regulatory guidance documents, are also covered in this chapter.
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