Maintaining GxP data integrity is a cornerstone of managing a successful clinical trial. Crucial to that is ensuring alignment with the FDA’s ALCOA+ principles.
At Arkivum we often see these principles being successfully applied to live data, but then not adapted to the different challenges presented when trying to retain digital content for the length of time required by regulators such as the EMA, EU and MHRA.
In this webinar recording, Arkivum’s Tom Lynam will take a look at the ALCOA+ principles through the lens of long-term data management. The session covers:
- What are the ALCOA+ principles?
- Which principles require a new approach for long-term retention
- What that approach looks like and what to consider
- Where to get started
- The session then concludes with a Q&A.
This session is designed for those relatively new to ALCOA+ and digital preservation.
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Suggested reading
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