Product overview
Aureon LIMS: a laboratory information management system for regulated work
Built for pharmaceutical QC, contract testing, biotech, and ISO/IEC 17025 labs that need a single record from accessioning through results, QC, deviations, and CoA.
Platform layers
Core first. Quality next. Enterprise when the network needs it.
Layer 01
Core LIMS
- Sample Management & Chain of Custody
- Test, Method & Specification Management
- Results Entry & Data Capture
- Instrument Integration
- Quality Control & SPC
- Deviation / OOS / CAPA
- Audit Trail & 21 CFR Part 11 Compliance
- User Management, RBAC & Training Compliance
Layer 02
Quality & compliance expansion
- Stability Management
- Inventory, Reagents & Consumables
- Batch & Lot Release
- Document & SOP Control
- Environmental Monitoring
- Change Control
- Electronic Lab Notebook (ELN)
- Reporting & Certificate of Analysis (CoA)
Layer 03
Enterprise & extensions
- Analytics, BI & Executive Dashboards
- Mobile & Barcode
- AI/ML assistive layer
- Multi-Site & Tenant Architecture
- CDS Integration
- Biobanking & Freezer Management
- Regulatory / eCTD export
- Supplier & Vendor Qualification
Specialized modules (LES, SDMS, invoicing, proficiency testing, and others) attach after the operational record is trusted. See the features hub.
Benefits by buyer
One record, three very different wins
Lab Manager / Ops
Throughput, turnaround, sample location, and workload without hunting across tools.
QA / Compliance
Part 11-oriented records, audit export, SOP-aligned methods, and CAPA that can actually close.
IT / Digital
Roles, integrations, deployment choice (cloud / on-prem / hybrid), and multi-site scope.
Implementation
Discovery → configure → validate → go-live
High-level motion. Duration depends on modules, interfaces, and your validation plan — we will not invent a universal timeline.
Step 01
Discovery
Map objects, methods, integrations, and validation scope.
Step 02
Configure
Core workflows, roles, and environments for your lab types.
Step 03
Validate
IQ/OQ support materials plus your protocols and approvals.
Step 04
Go-live
Pilot, cutover, and a record the bench will actually use.
Architecture
Architecture, in marketing language
Modular monolith with clear module boundaries. Built for regulated environments: no hard deletes of regulated data; status lifecycles instead. Optional technical note for IT: ASP.NET Core API, SQL Server, web admin dashboard.
Aureon LIMS is designed to support 21 CFR Part 11 and ISO/IEC 17025 workflows. It is not FDA-approved or “Part 11 certified.” Customers remain responsible for system validation, SOP alignment, and regulatory interpretation in their own quality system.
Aureon is a modular monolith: one coherent platform with clear module boundaries, so you can expand without rip-and-replace. The backend is an ASP.NET Core API with SQL Server; operators use a web admin dashboard.
Walk the product with your methods in mind
Demo for evaluators. Sales for scope, validation packages, and deployment.