© 2024 IQVIA - All Rights Reserved

Skip to end of metadata
Go to start of metadata

You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 3 Next »

Introduction

From GAMP 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.

It is important to note that archiving and retrieval is different to backup and restore of data.

Archiving and Retrieval

ClinSpark is provided as Software as a Service (SaaS) on Amazon Web Services (AWS).

Due to the modern nature of ClinSpark's data infrastructure, study 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.

Participant information may be removed under carefully restricted circumstances in order to support a ‘Persons right to be forgotten’ per the EU GDPR Regulation.

See https://foundryhealth.atlassian.net/wiki/spaces/DOCS/pages/3715236246/Supporting+GDPR+right+to+erasure+requests+of+volunteer+data?src=search

References

  1. GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2008

  2. https://gdpr.eu/right-to-be-forgotten/

  • No labels