Pharmaceutical QC and GMP labs, contract testing laboratories, biotech and analytical R&D, and food, environmental, or calibration labs aligning to ISO/IEC 17025 — including multi-site networks.

Is Aureon 21 CFR Part 11 certified?

No. Aureon is designed to support 21 CFR Part 11 and ISO/IEC 17025 workflows. Customers remain responsible for validation and regulatory interpretation. We do not claim FDA approval or Part 11 certification.

Can we start with core LIMS and add modules later?

Yes. The platform is modular. Most laboratories begin with sample, test, result, QC, audit trail, and users — then expand into stability, inventory, ELN, analytics, mobile, or multi-site.

Cloud, on-premises, or hybrid. IT and quality decide the topology during discovery based on data residency, validation, and network constraints.

NewAureon LIMS · Stability & multi-site modules

The LIMS built for regulated labs — from sample to CoA

One system of record for accessioning, custody, results, QC, and release documentation — designed to support 21 CFR Part 11 and ISO/IEC 17025 workflows.

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Part 11-oriented audit trail
ISO/IEC 17025 ready
Cloud, on-prem, hybrid

Pipette dispensing into a rack of sample tubes

Fluorescence microscopy image of stained cells

Built around the standards regulated labs answer to

21 CFR Part 11ISO/IEC 17025Immutable audit trailE-signaturesChain of custodyOOS & CAPACertificate of AnalysisStability studiesInstrument integrationMulti-site21 CFR Part 11ISO/IEC 17025Immutable audit trailE-signaturesChain of custodyOOS & CAPACertificate of AnalysisStability studiesInstrument integrationMulti-site

Lifecycle stages on one record

Modules that attach without rip-and-replace

Deployment models: cloud, on-prem, hybrid

Changes kept as attributable audit events

The problem

Spreadsheets and fragmented tools fail audits and slow release

When sample location, results, deviations, and CoA live in different places, turnaround suffers and the inspection story has to be reconstructed.

Audits get reconstructed

History lives in email, binders, and spreadsheets.

Samples go missing

Location and custody aren't tied to the result.

Integrations break

Every new tool is another brittle hand-off for IT.

Analyst examining a specimen under a microscope

Barcoded laboratory sample vials in a storage box

Audit finding

Missing custody record

SMP-1187 · spreadsheet v14_final.xlsx

The platform

Everything that holds the laboratory record together

Aureon LIMS is an enterprise-grade LIMS for testing, QC, and regulated labs — modular, audit-first, and built for the full sample lifecycle.

End-to-end sample lifecycle

Accession, storage, custody, aliquots, and disposition — with lineage you can follow.

Compliance by design

Immutable audit trail, e-signatures, and attributable changes.

QC and quality operations

OOS, deviation, and CAPA bound to the laboratory record.

Automated analyzer lab with a scientist at work

Instrument and data flow

Results in from instruments. Fewer transcription steps. CoA from approved data.

Modular expansion

Add stability, inventory, ELN, analytics, mobile, and multi-site as you grow.

Release-ready reporting

Certificates generated from approved, signed data only.

Trusted workflow

Five steps. One unbroken record.

Scroll to follow the sample

Sample

Barcode at receipt, capture chain of custody, and place every container in a known location.

Accession · Custody · Storage

Test

Assign methods and specifications, schedule analysts, and pull instrument data straight into the run.

Methods · Worklists · Instruments

Result

Calculated values checked against spec limits in real time, with review and approval on the record.

Spec checks · Review · E-signature

Gloved scientist pipetting samples into tubes

QC

Trend controls, raise OOS and deviations, and drive CAPA without leaving the laboratory record.

SPC · OOS · CAPA

Quality review of laboratory release documentation

CoA

Generate certificates from approved data only — consistent, signed, and ready to release.

Templates · Release · Export

Scientist wearing safety glasses in a bright lab

Result approved

e-sig · J. Rivera · 14:02 UTC

Compliance by design

Built for the day the inspector asks

Every change is attributable. Every signature carries its meaning. Every correction is a new event — never an overwrite.

21 CFR Part 11

Records, signatures, and audit trail — designed to support, not certified.

ISO/IEC 17025

Methods, sample handling, competence, and records aligned to assessment topics.

Audit trail

Append-only history. Corrections are new events.

E-signatures

Meaning, identity, and timestamp bound to the record.

Explore compliance

Industries

Built for labs that cannot lose the trail

All solutions

Pharmaceutical QC analyst reviewing sample vials

Regulated

Pharma QC / GMP

Batch release, stability, and inspection-ready records.

High volume

Contract testing

Client portals, turnaround tracking, and clean CoAs.

Biotech research laboratory with culture equipment

Flexible

Biotech / R&D

Structured experiments that graduate into GMP.

Food and environmental testing samples on a laboratory bench

Accredited

Food / Env / ISO 17025

Method validation, competence, and uncertainty.

The work we design for

Placeholder quote — replace with a real QA or lab-operations statement about audit readiness or turnaround.

Name, title, laboratory — [ASSETS]

Customer logos and named quotes will appear here once approved. Until then, these are the laboratory environments the product is built around — not invented client marks.

Glass vials and ampoules on a dark background

Row of microscopes on a teaching lab bench

Questions

Direct answers for evaluators

Can't find what you need? Our team answers security, validation, and scoping questions directly.

Aureon LIMS is an enterprise laboratory information management system for regulated labs. It covers the sample lifecycle from accessioning through results, QC, deviations/CAPA, reporting/CoA, and compliance — with modules for quality, analytics, mobile, and multi-site expansion.

See your own methods running in Aureon

A tailored walkthrough for QA, lab operations, and IT — built around your sample types.

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Talk to sales

Contact sales from here

For a product walkthrough use the demo request. This form is for commercial, security, and scoping questions.

Emailsales@aureonlims.com
Phone+1 (617) 555-0148
HQCambridge, Massachusetts
RegionsNorth America, Europe, and APAC

Real specialists. Replies scoped to your lab — never a generic deck.