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Introduction
From GAMP5GAMP 5, Appendix O13
Archiving is the process of taking records and data off-line by moving them to a different location or system, often protecting them against further changes. It may also be necessary to retain in archive the applications that support the records and data. Archived records should be readily retrievable for business or regulatory purposes.
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Due to the modern nature of ClinSpark's data infrastructure, study data archival is not required for ClinSpark customers. With very high database storage capacity, highly optimized database structure and powerful server infrastructure, ClinSpark can meet all currently forecasted data storage and performance targets, even with years of customer data in place. Study data are not removed from ClinSpark.
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Participant information may be removed under carefully restricted circumstances in order to comply with a ‘Persons right to be forgotten’ per the EU GDPR Regulation. |
References
GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2008