# Tamper-proof documentation of pharmaceutical samples

> ARTiFACTS and the University of Notre Dame’s Distributed Pharmaceutical Analysis Laboratory developed a blockchain application for tamper-proof tracking of pharmaceutical samples. A live test in July 2022 demonstrated continuous recording of sample provenance, metadata, transfers and analytical results from PAD and HPLC examinations. Rollout then began within the participating DPAL research community, although broader efficiency metrics have not been published.

**Sector:** Quaternary sector · **Industry:** Research institutes · **Organisation:** ARTiFACTS, Distributed Pharmaceutical Analysis Laboratory (DPAL), University of Notre Dame · **Maturity level:** Production

Canonical URL: https://www.sapientblock.com/en/use-cases/artifacts-arzneimittelproben-manipulationssicher-dokumentieren

## Documentation status

- **Project status:** Production
- **Evidence:** Evidence medium
- **Editorial review:** pending

## Description

The organisations ARTiFACTS and the Distributed Pharmaceutical Analysis Laboratory of the University of Notre Dame introduced a distributed ledger solution to log the handover and analysis of pharmaceutical samples in a tamper-proof manner. The system connects distributed research institutes and ensures that all steps from sample intake to the final chemical test report are documented seamlessly and immutably. In this way, laboratories can jointly tackle substandard and falsified medicines without relying on error-prone manual logs.

As part of the collaboration between ARTiFACTS and the DPAL network, a system was developed that digitally secures the chain of custody for pharmaceutical samples. A broad live test in July 2022 demonstrated the practical viability of the platform, involving various university locations. During this trial, geographic provenance, substance metadata, and the results of paper analytical device tests and high-performance liquid chromatography were captured in a tamper-proof manner. A multi-tiered authorisation concept protects sensitive research data, whilst the cryptographic audit trail guarantees the integrity of the entire analytical chain. Following the successful proof, the phased rollout to the DPAL community commenced, with further scaling and efficiency data remaining unpublished to date.

## Benefits

- Standardised data exchange via cross-institutional interfaces
- Clear proof of sample provenance for collaborating partners
- End-to-end traceability of all sample movements between participating institutes
- Protection of scientific measurement data against subsequent tampering
- Increased transparency in combating falsified medicines
- Simplified documentation of test results such as PAD and HPLC values
- Clear accountability of responsibilities during sample handovers

## Challenges

- Effort required to integrate independent university laboratories into a shared governance framework
- Standardisation of measurement data and interfaces across disparate laboratory systems
- Reliance on reliable manual data entry at sample handover points
- Onboarding and training effort for laboratory staff regarding new digital recording processes

## Technology foundation

The solution uses a distributed ledger for the cryptographic logging of handover records, metadata, and laboratory tests. This technology ensures an immutable audit trail across organisational boundaries, ensuring scientific data remains tamper-proof and linked to specific samples.

## Sources

- [New system for tracking DPAL samples and data piloted](https://padproject.nd.edu/project-updates/new-system-for-tracking-dpal-samples-and-data-piloted/)
- [Securing the Chain of Custody and Integrity of Data](https://pmc.ncbi.nlm.nih.gov/articles/PMC9907419/)