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Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities. Understanding and following the ALCOA+ principles and how ClinSpark supports the ALOCOAALCOA+ principles are essential for understanding requirements for data integrity.
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a robust and reliable backup system
data recovery processes
resilient infrastructure
cybersecurity
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Note
ClinSpark continuously streams data to remote storage in a different availability zone
Data restoration processes are automated
ClinSpark is hosted by AWS, the largest hosting provider in the world
The ClinSpark platform has been designed and implemented with security at its core
Available
Data must not only exist but must be accessible for audits, reviews and inspections.
data must be searchable
data must be properly indexed and labelled
readable at any time during the retention period
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Notes
ClinSpark supports filtering of data in the user interface
Data can be exported for filtering, viewing and searching in third-party tool
System owners have full control over the visibility of data in the retention period
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Useful links
Guidance for Industry Electronic Source Data in Clinical Investigations