Engineered capability
Healthcare & Pharma
GxP- and HIPAA-aligned clinical and pharmaceutical platforms — engineered across discovery, validation, and supply integrity for regulated execution.
02 — Engineering practice
How we engineer it.
Healthcare and pharmaceutical systems do not allow ambiguity. Regulation, patient safety, and supply integrity require platforms that are validated by construction, auditable on demand, and recoverable under failure — across discovery, clinical operations, and regulated manufacturing.
Our practice spans HL7/FHIR clinical integration, EHR ecosystems, GxP-aligned LIMS and MES platforms, and 21 CFR Part 11 electronic records. Every engagement is engineered against the applicable controls — IQ/OQ/PQ where required, electronic signature where required, audit trail without exception.
Validation is not a phase; it is a discipline. We engineer the validation surface alongside the platform itself, so that regulator evidence is generated continuously, change is governed by impact assessment, and the platform stays in a validated state through every release cycle.
03 — Engineering surface
The technologies behind this capability.
A selection of the platforms, frameworks, and tools our principals engineer with in production engagements.
Clinical & Regulatory
- HL7 / FHIR
- OMOP CDM
- 21 CFR Part 11
- GxP / IQ-OQ-PQ
- GAMP 5
Platforms
- Epic / Cerner integration
- Veeva Vault
- LIMS (LabWare, STARLIMS)
- MES (Werum PAS-X)
- OpenEHR
Security & Operations
- PHI-grade access controls
- HSM-backed key management
- Audit lake (immutable)
- OpenTelemetry
- PagerDuty
Engage on this capability
Scope this capability against your operating model.
Briefings are scoped within five working days and led by a senior architect.
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