ISO 17025 Accredited Platform

The Modern Lab OS.

PureLIMS® NextGen is a comprehensive LIMS built for regulated laboratories — with ISO 17025 workflows, immutable audit trails, AI-assisted validation, and a client portal your customers will actually use.

ClinicalEnvironmentalFood SafetyPharmaceuticalCannabisMaterials
PureLIMS NextGen — Sample Tracking
Received
Prepared
Analyzed
QA Review
Report Released
Sample ID
LAB-2026-00847
Client
Acme Laboratories
Test Panel
Full Compliance
0+
Lab Industries Served
0+
Active Users
0%
Uptime SLA
ISO 17025
Accredited
0 CFR Pt 11
Compliant

Everything a modern lab needs. Nothing it doesn't.

Purpose-built for ISO 17025 accredited operations across multiple industries and regulatory frameworks.

End-to-End Workflow

Sample request, accessioning, instrument ingestion, QC/QA, report release, regulatory reporting, and invoicing. One system. Zero gaps.

Immutable Evidence Vault

Every raw data file, report, photo, and signature stored with SHA-256 hash verification and WORM-like immutability. Audit-ready on demand.

AI-Assisted Validation

AI flags mapping errors, outliers, and impossible values before they become a compliance problem. Humans always make the final decision.

Multi-Jurisdiction Configuration

Configurable panels, analytes, action limits, and report templates per jurisdiction and lab type. Add new configurations without code changes.

Client Portal (White-Label)

Give clients real-time sample milestone visibility. White-label per brand. Only QA-released results are ever visible.

Compliance Cockpit

One-screen audit readiness: missing signatures, overdue calibrations, open CAPAs, QC failures, custody gaps. One-click export.

Instrument & ERP Integrations

Configurable connector framework with submission queues, automatic retries, reconciliation, and full error triage for any instrument or ERP.

21 CFR Part 11 Audit Trails

Computer-generated, timestamped, immutable audit logs. E-signatures with identity, timestamp, meaning, and record linkage at every critical control point.

AI Infrastructure

Dedicated AI gateway with embeddings, RAG search, anomaly detection, and SOP assistant. Fully provenance-logged with zero data leakage.

Purpose-built for your industry

PureLIMS is configured — not customized — for each lab type. Select your industry to see how it fits.

EPA-compliant testing for water, soil & air

Multi-matrix, multi-method, multi-state environmental testing with chain-of-custody, EPA method compliance, and regulatory reporting built into every workflow.

Learn more about environmental labs

Key capabilities

  • EPA 500/600/200/8000 method templates
  • Digital chain-of-custody with e-signatures
  • Multi-state regulatory reporting & EDD generation
  • ICP-MS, GC-MS, IC instrument integration
AI-Powered

Intelligence built into every workflow

PureLIMS embeds AI where it matters — validation, search, monitoring, and reporting — with humans in control of every decision and full provenance on every action.

AI-Assisted Validation

Flag outliers, mapping errors, and impossible values before they reach QA review.

Natural Language Queries

Ask questions in plain English and get instant answers from your lab data.

Anomaly Detection

Continuous monitoring of instrument data with automatic alerts on deviations.

Smart Dashboards

Real-time KPI dashboards for turnaround times, volumes, and compliance status.

SOP Assistant

RAG-powered assistant that helps analysts find SOPs and answer procedure questions.

Provenance Logging

Every AI decision is logged with full provenance — no black boxes, ever.

From sample request to invoice. One system.

Every step logged, every handoff tracked, every decision auditable.

Client Submits Request

Online sample submission with pre-configured test panels per lab type

Portal Logged

Courier Pickup + Chain of Custody

Chain of custody begins at pickup with proof of delivery tracking

Evidence Vault

Lab Receives + Accessions

Barcode scan, weight verification, photo capture, condition logging

Part 11 Logged

Instrument Ingestion + AI Validation

Raw data ingested, AI flags outliers and mapping errors automatically

AI Validated

QC Gate

Calibration verification, blank checks, duplicate precision, spike recovery

ISO 17025

QA Approval + E-Signature

Two-person review with 21 CFR Part 11 compliant electronic signatures

Part 11 Signed

Report Released

Final report generated, client notified, regulatory submission queued

Report Issued

Invoice Generated

Automated invoicing based on completed tests with line-item detail

ERP Synced

Trusted across regulated industries

PureLIMS serves laboratories in every major regulated sector — with compliance frameworks, workflows, and integrations built for each.

Environmental
Cannabis
Food Safety
Pharmaceutical
Clinical
Materials
ISO 17025
Accredited workflows
21 CFR Part 11
Compliant audit trails
CLIA
Clinical lab ready
GLP/GMP
Good practice support

Integrates with your ecosystem

AgilentWatersShimadzuThermo FisherPerkinElmerSAPSageQuickBooksOpenTelemetryHL7 FHIR

Compliance Certifications

ISO/IEC 1702521 CFR Part 11CLIA CompliantGLP/GMP ReadyHIPAA Aware

Built by laboratory operators, for laboratory operators.

PureLIMS NextGen is the culmination of years of real-world laboratory operations across clinical, environmental, food safety, and cannabis testing.

Schedule a Demo