Reproducibility and accountability are not checkboxes. They are the foundation of trustworthy science, defensible regulatory submissions, and research that holds up under scrutiny — months, years, or decades later.
We build open-source R tooling that makes reproducibility and auditability automatic, verifiable, and actionable — for academic, clinical, and pharmaceutical settings alike.
Packages addressing reproducibility, auditability, and data provenance in GxP analytical workflows. Designed for environments operating under FDA, EMA, and ICH requirements.
| Description | CI | CRAN | |
|---|---|---|---|
| reproducr | Behavioural reproducibility auditing — scan scripts, certify outputs, detect drift |  |
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| regulog | Tamper-evident, hash-chained electronic audit logging — 21 CFR Part 11 and EU Annex 11. Ships with IQ/OQ/PQ qualification scripts |  |
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| lineager | Row-level data provenance for clinical datasets — full traceability from SDTM to ADaM, mandatory exclusion documentation, CONSORT-style disposition tables |  |
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Contributions are welcome — bug reports, feature requests, documentation improvements, or new functionality. Open an issue in the relevant package repository.
reprostats.org ·
Blog ·
Antwerp, Belgium