Tamper-proof documentation of pharmaceutical samples
Sector: Quaternary sector · Industry: Research institutes · Organisation: ARTiFACTS, Distributed Pharmaceutical Analysis Laboratory (DPAL), University of Notre Dame · Maturity level: Production
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.
Documentation status
- Project status: Production (as of 01 July 2022) — Successful proof of concept with real users and samples; subsequent rollout across the DPAL community, without published scaling metrics.
- 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proof, the phased rollout to the DPAL community commenced, with further scaling and efficiency data remaining unpublished to date.
Perspectives
B2B — organisations perspective
The application provides research institutes and collaborating partners with a reliable standard for sharing sensitive analytical data. Partner organisations can independently verify the provenance of samples and share analytical results with audit security without a central intermediary.
Employees perspective
Laboratory staff are supported in logging sample handovers and test results through structured digital workflows. This reduces the effort required for subsequent reconciliations between institutes, but demands careful input of standardised metadata.
Benefits
General
- 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
B2B — organisations
- Standardised data exchange via cross-institutional interfaces
- Clear proof of sample provenance for collaborating partners
Employees
- Simplified documentation of test results such as PAD and HPLC values
- Clear accountability of responsibilities during sample handovers
Challenges
General
- Standardisation of measurement data and interfaces across disparate laboratory systems
- Reliance on reliable manual data entry at sample handover points
B2B — organisations
- Effort required to integrate independent university laboratories into a shared governance framework
Employees
- 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.
Implementation examples
DPAL Chain of Custody Tracking
In the distributed investigation of suspect medicines, there was previously no standardised and tamper-proof method to verify sample handovers and analytical data across multiple independent laboratories.
ARTiFACTS and the University of Notre Dame developed a blockchain system for the end-to-end tracking of pharmaceutical samples and their laboratory analyses.
In July 2022, the partners conducted a practical live test involving several universities worldwide. Physical sample handovers and the associated measurement results from paper analytical device tests and HPLC examinations were immutably stored on a distributed ledger. The system established a role-based permissions model to precisely manage access to sample and quality data. Following the successful trial, rollout of the system to the entire DPAL research community began.
The solution addressed the risk of data loss, allegations of manipulation, and incomplete audit trails during global collaboration among university analytical centres.
Tags
Chain of Custody, Pharmaceutical safety, Laboratory analytics, Provenance, Data integrity