Quality and Traceability of Starting Materials from Supplier to Recipient.

ABSTRACT

Quality of processes and products is based on traceability and review of both components, material processing and product flow throughout the manufacturing and supply chain. Blockchain technology enables cross-border audit trail and traceability while reducing costs. Donors are the providers of biological raw material (starting material). They can share their health records when donating by using an IPS document or a FHIR Questionnaire-response resource. It allows health personnel to retrieve and verify relevant clinical information when donating. Additionally, health personnel can generate an anonymized and de-identified digital twin of the donor for research purposes, and it can be updated over time. The starting material can include a reference to a digital twin of an unknown supplier, which improves the data quality and enhances research possibilities. Adverse reactions and events can be also recorded on blockchain to improve safety, transparency, traceability, medical research and product quality.