Draft summary

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: This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). Customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can use this document in 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.