Features built for regulated labs
PureLIMS NextGen provides every capability a modern ISO 17025 accredited laboratory needs — from sample intake to final report, with full regulatory compliance built in.
Request a DemoEnd-to-End Workflow
Sample request, accessioning, instrument ingestion, QC/QA, report release, regulatory reporting, and invoicing. One system. Zero gaps.
- Online sample submission with pre-configured test panels
- Barcode-driven accessioning with photo capture
- Instrument data ingestion with automatic mapping
- Multi-level QC/QA review with e-signatures
- Automated report generation and client notification
- Regulatory submission queue with retry logic
- Line-item invoicing synced to ERP
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.
- SHA-256 hash verification on every stored artifact
- WORM-like immutability prevents tampering
- Full chain of custody from pickup to report
- One-click audit export with integrity proof
- Configurable retention policies per record type
- Automatic backup with geographic redundancy
AI-Assisted Validation
AI flags mapping errors, outliers, and impossible values before they become a compliance problem. Humans always make the final decision.
- Automatic outlier detection on incoming results
- Mapping error identification before data commit
- Impossible value flagging based on analyte ranges
- Historical trend analysis for early warning
- Human-in-the-loop approval for every AI suggestion
- Full provenance logging of AI decisions
Multi-Jurisdiction Configuration
Configurable panels, analytes, action limits, and report templates per jurisdiction and lab type. Add new configurations without code changes.
- Per-jurisdiction analyte panels and action limits
- Configurable report templates per lab type
- Multi-language support for client-facing reports
- Regulatory framework mapping (ISO, CLIA, GLP)
- No-code configuration interface for lab managers
- Version-controlled configuration with rollback
Client Portal (White-Label)
Give clients real-time sample milestone visibility. White-label per brand. Only QA-released results are ever visible.
- Real-time sample milestone tracking
- White-label branding per client organization
- QA-released results only visible to clients
- Secure document download with audit logging
- Client-initiated sample submission requests
- Notification preferences per client user
Compliance Cockpit
One-screen audit readiness: missing signatures, overdue calibrations, open CAPAs, QC failures, custody gaps. One-click export.
- Real-time audit readiness dashboard
- Missing signature and approval tracking
- Overdue calibration alerts with escalation
- Open CAPA tracking and resolution workflow
- QC failure trend analysis and reporting
- One-click audit export in multiple formats
Instrument & ERP Integrations
Configurable connector framework with submission queues, automatic retries, reconciliation, and full error triage for any instrument or ERP.
- Pre-built connectors for major instrument vendors
- Configurable data mapping per instrument type
- Submission queues with automatic retry logic
- Reconciliation dashboard for data integrity
- Full error triage with notification workflow
- ERP sync for invoicing and inventory
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.
- Computer-generated, timestamped audit entries
- Immutable log storage with integrity verification
- E-signatures with identity and meaning capture
- Record linkage at every critical control point
- Configurable audit trail scope per workflow
- Export-ready for FDA inspection
AI Infrastructure
Dedicated AI gateway with embeddings, RAG search, anomaly detection, and SOP assistant. Fully provenance-logged with zero data leakage.
- Dedicated AI gateway with access controls
- Embedding-based search across all lab data
- RAG-powered SOP assistant for analysts
- Anomaly detection on instrument data streams
- Full provenance logging of every AI interaction
- Zero data leakage architecture with tenant isolation
PureLIMS vs. Legacy LIMS
See how PureLIMS NextGen compares to traditional laboratory information management systems.
| Feature | PureLIMS NextGen | Legacy LIMS |
|---|---|---|
| End-to-End Workflow | ||
| Immutable Evidence Vault | ||
| AI-Assisted Validation | ||
| Multi-Jurisdiction Config | ||
| White-Label Client Portal | ||
| Compliance Cockpit | ||
| Instrument Integrations | ||
| 21 CFR Part 11 Audit Trails | ||
| AI Infrastructure | ||
| No-Code Configuration | ||
| Real-Time Dashboards | ||
| Modern REST/GraphQL API |
Ready to modernize your lab?
Schedule a personalized demo and see how PureLIMS NextGen can transform your laboratory operations.
Schedule a Demo