Audit-ready by design. Continuously.
Regulatory posture is not a project — it is a property of the platform. NextGen LIS keeps your laboratory inspection-ready every day of the year.
CLIA
Clinical laboratory workflow, personnel, and reporting compliance.
CAP
Checklist-driven documentation, competency, and QC evidence.
COLA
Continuous quality and operational conformance.
FDA
Design controls and evidence for regulated diagnostic devices.
21 CFR Part 11
Electronic signature, audit trail, and record integrity.
HIPAA
PHI protection across the platform lifecycle.
ISO 15189 / 17025
International laboratory quality standards.
GxP
GLP, GMP, and GCP-aligned controls for regulated environments.
Audit Readiness
Continuous audit posture, not year-end scramble.
Electronic Signatures
Compliant e-sign for every controlled action.
Validation
IQ, OQ, PQ evidence maintained inside the platform.
Quality Documentation
Living SOPs, controlled forms, and revision history.
Document Control
Effective-dated documents with signature workflows.
Change Management
Governed changes with traceability and impact analysis.
Inspection Readiness
Inspector-facing views and one-click evidence exports.
Schedule a Demo
See NextGen LIS in your laboratory.
Speak with a solutions architect. Explore the platform. Design an implementation tailored to your operational, regulatory, and scientific requirements.