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:

1. 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);
2. 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);
3. 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 organizations in the domain);
4. manufacturing devices or software for the aforementioned tasks or providing facilities for these tasks.

This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation).

This document can be used by customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others for confirming or recognizing the competence of the aforementioned parties.

This document does not apply to biological material and data used for medical diagnosis, treatment and therapy.

NOTE 1        This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine.

NOTE 2        International, national, or regional regulations, standards, or requirements can apply to specific topics covered in this document, e.g., for organizations handling human materials procured and used for diagnostic and treatment purposes.