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.
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.
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 LoggedCourier Pickup + Chain of Custody
Chain of custody begins at pickup with proof of delivery tracking
Evidence VaultLab Receives + Accessions
Barcode scan, weight verification, photo capture, condition logging
Part 11 LoggedInstrument Ingestion + AI Validation
Raw data ingested, AI flags outliers and mapping errors automatically
AI ValidatedQC Gate
Calibration verification, blank checks, duplicate precision, spike recovery
ISO 17025QA Approval + E-Signature
Two-person review with 21 CFR Part 11 compliant electronic signatures
Part 11 SignedReport Released
Final report generated, client notified, regulatory submission queued
Report IssuedInvoice Generated
Automated invoicing based on completed tests with line-item detail
ERP SyncedIntegrates with your ecosystem
Compliance Certifications
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.
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