Biotechnology. Provenance information model for biological material and data - Design concepts and general requirements
Biotechnology. Provenance information model for biological material and data - Design concepts and general requirements
1 Scope This document specifies a general concept for provenance information of biological material and data, organizational roles, and requirements for provenance information management. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are:
acquiring, collecting, processing, testing, analysing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); generating, collecting, analysing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); generating, collecting, analysing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizati...
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