EXECUTABLE ARCHIVES: Software integrity for data readability and validation of archived studies

Abstract

Long-term readability of electronic data is a key regulatory requirement for archived data integrity in life sciences and pharmaceutical research. However, this has been difficult to achieve within current data and software preservation practice due to data dependence on specialty software which becomes unusable as a result of rapid obsolescence of hardware and operating systems. This paper introduces a novel Executable Archive framework that extends traditional data archives with a platform for hosting legacy software and with processes for installing, use, and long-term maintenance of the software. Through a case study of a scientific software de-commissioning, we demonstrate the use of the framework for designing a solution for GLP-compliant software transition from operational to archival use and a secure processing of raw archived data to reconstruct past research studies. The framework is flexible and opens up opportunities for preservation planning and action that consider both data access and software management together, ensuring that the archived data integrity is fully supported by the long-term software integrity.

Details

Creators
Natasa Milic-Frayling; Marija Cubric
Institutions
Intact Digital Ltd; University of Hertfordshire
Date
Keywords
data integrity; software integrity; study reconstruction; significant properties; executable archive
Publication Type
paper
License
CC BY 4.0 International
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