Roadmap and status

lims-core began as a thin vertical slice and has grown into a broad, working build across the biobank and analytical workflows, still on the same production-shaped compliance core. This page is the honest summary of where the line is. The full, code-checked gap analysis is the completeness review; the architecture and build plan are in plan.md.

Where the line is

What lims-core does, it does the way a modern auditable system should: the audit trail, e-signatures, chain of custody, and least-privilege enforcement live in the database as triggers and roles, not in application code a bug could bypass. Every regulated behavior added since the slice landed with an ADR, a requirement ID in the schema, and a compliance test.

It is still not a validated production system for running a regulated trial biobank, and not a drop-in replacement for a large commercial LIMS. Those products carry an enormous functional surface — stability studies, electronic lab notebooks, no-code workflow designers, broad instrument integration — and a formal validation package (IQ/OQ/PQ) that attaches to a specific installation. The honest framing is an open, modern nucleus you can grow into that kind of platform, not a replacement you can install next quarter.

Working today

Covered by tests that run against a real Postgres in CI:

Core and compliance. Append-only hash-chained per-study audit trail with one-click verification, versioned four-eyes results, re-authenticated e-signatures, grant-based RBAC scoped to study/site, OIDC and local authentication, and database-enforced immutability.

Biobank. Specimen accession with EDC subject reference (never PHI); aliquot and derivation lineage with conserved volume/quantity, single-parent derivation and many-parent pooling, freeze-thaw counts and concentration; shipments with a pack → ship → receive custody handoff; outbound collection kits; count-based bulk accessioning and CSV manifest import; an interactive freezer map with click-to-place/move and a one-occupant-per-position constraint; consent-withdrawal holds (sample- or subject-wide, propagated to descendants) and terminal supervisor-only disposal.

Analytical / QC. Per-service acceptance criteria evaluated at result entry; calculated results via a safe expression engine; worksheets/runs that consume reagent lots through the inventory ledger; QC control samples with single- and multi-observation Westgard rules; a run-level QC release gate; Certificate-of- Analysis PDFs; and a read-only QC review board with Levey-Jennings trending.

Inventory and reporting. A lab-wide reagent/lot catalog with expiry and an append-only consumption ledger; study-scoped inventory counts, turnaround metrics, and a PHI-free manifest CSV export.

Still open

The nearest edges, from the completeness review:

• Biobank depth — multi-level lineage-graph visualization and proportional pooling ratios; kit → collected-sample linkage and par-level kit inventory; drag-and-drop and multi-select freezer-map moves; sample request, reservation, and distribution workflows.
• Analytical / QC — control-type distinctions (blanks/spikes/duplicates vs. level controls), the across-two-levels within-run Westgard rules (cross-level 2-2s, R-4s), per-service configurable rule selection, and instrument integration; stability studies and ELN/SDMS-style raw-data capture.
• Instrument and interfaces — instrument registry and calibration scheduling; instrument result capture (ASTM/LIS2-A2, HL7v2) and automation; an integration API for EDC/CTMS and external systems.
• Operations and platform — dashboards and trend/ad-hoc analytics; notifications and temperature-excursion monitoring; a configurable workflow state machine; document/SOP management; a label-template designer; deviation/ CAPA; data retention/archival; and a formal validation package.

Where lims-core is ahead

Worth stating, because it is the reason to invest: the compliance substrate — tamper-evident hash-chained audit, DB-enforced immutability, a least-privilege runtime role, re-auth e-signatures, per-study audit scoping — is modern and cleanly separated, and the stack (TypeScript, Postgres, React) is a far easier hiring and maintenance story than a legacy Java/Oracle LIMS.