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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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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