Solutions / Regulated life sciences
Primary pathwayThe evidence changed. What does that affect?
A structure is revised. A reference dataset is superseded. A guideline is updated. Downstream sit conclusions, approvals and submissions that depended on the old version, and somebody has to work out which are still valid.
Two responses, both unsatisfying
Revalidate broadly
Slow, and it consumes expert time that was never budgeted for.
Judge what was affected
Works until an auditor asks how the judgement was reached and what record exists.
The gap is not detection. Version control already tells you something changed. The gap is consequence: which downstream work depended on the part that changed, which did not, and what evidence exists that the line was drawn correctly.
DELA does the work here
Deterministic Evidence Lineage Architecture
The underlying evidence changed. What does that affect?
DELA detects changes in scientific, operational or other source evidence, traces the affected dependencies, preserves the work that remains valid, selectively replays reproducible operations, and routes non-reproducible work to qualified human review.
What each of them needs to see
| Role | What they need before this proceeds |
|---|---|
| Quality and validation | Must show a computerised process behaved as intended, and that a change was assessed rather than assumed. |
| Regulatory affairs | Must know whether a submission still rests on current evidence, and be able to demonstrate it. |
| Risk and internal audit | Need an artefact they can examine independently, not a vendor assurance. |
| Scientific and data leads | Want the definition of a material change agreed in writing before anything is automated. |
The gates that do the checking
This page exists because these implementations exist. We do not publish an industry page without gates behind it.
BioChangeGate
Open sourceScientific state diffs, dependency impact, selective replay and sealed evidence. The reference implementation of the DELA layer.
FoldInputGate
Open sourcePre-flight checks for structured prediction job metadata before a run is accepted.
ConfidenceGate
Open sourceConfidence-contract routing for predicted structures. Turns a confidence band into a routing decision rather than a caveat.
ProvenanceGate
Open sourceProvenance continuity checks for scientific AI artefacts. Detects a broken chain between an artefact and its source.
MedGate
Interactive labClinical decision-support checks covering dose binding, oncology dosing limits, interactions and paediatric restrictions.
ReplayGate
Interactive labRe-runs sealed evidence packs to detect verification drift over time.
What this is not
- EcoKure does not verify scientific or biological truth. It governs the computational consequences of a change in evidence.
- It does not replace your quality management system, your validation process or your electronic lab notebook.
- MedGate is decision-support verification for evaluation only. It is not a registered medical device.
- EcoKure holds no GxP certification. Controls are built to be auditable; certification is a path, not a present state.
Start with one workflow
The useful first conversation is thirty minutes on a workflow where a change in rules or evidence has already cost you work. Both sides find out quickly whether this is worth pursuing.
Where it sits in what you already run
Nothing is replaced. The runtime deploys in your own account, so the only thing crossing the seam is a decision request one way and a verdict with its evidence coming back.
What one decision actually does
The same runtime and the same evidence contract as every other pathway. What changes is the control pack and the workflow.