Whitepaper: Long Term Digital Preservation of GxP Health and Life Sciences Data
The HSRAA and Arkivum have worked together to create this whitepaper on how digital preservation can be applied to GxP data in health and life sciences.
Authors
- Matthew Addis Arkivum Ltd. Digital Preservation (Sections 4 – 8)
- Bob Thompson HSRAA Committee Member. Introduction (Section 2)
- Jamie Toth SAG Director. Regulatory Overview (Section 3)
Reviewers
- Neil Gow: UCB Pharma
- Marion Mays: Jerion Consulting Group
The target audience for this white paper is records managers, archivists, quality assurance and IT professionals. The aim is to explain what digital preservation is, why it is needed and how it can be achieved. The broad requirement from regulatory bodies such as the EMA, FDA, MHRA and PMDA is that the records should remain retrievable and accessible for as long as they are required to be accessed, both by these bodies and by the record owners themselves. In addition, dynamic data must remain so, and not be ‘flattened’ as part of retention. The requirement is very plain, but the method is not explained in the guidelines. The what and the why is regulatory requirements, the how is digital preservation. The following white paper seeks to explain the how so organisations can achieve the what and the why.
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