The Compliance
Operating System
for Modern Labs
Dynamic SOPs. AI-powered compliance intelligence. Inspection resilience. Built for laboratories that cannot afford to fail a survey.
If you manage a laboratory,
these keep you up at night.
Every lab director we've talked to shares the same four fears. LabGuard was built to eliminate every one of them.
"My SOPs haven't been reviewed since I last hired someone to do it."
Static documents go stale. CLIA requires annual review of every SOP. Most labs are out of compliance and don't know it.
"I'm never sure if we're inspection-ready until the inspector walks in."
Inspections come unannounced. Without a real-time readiness system, you're always guessing — and guessing wrong.
"Tracking competency for 12 staff across 40 analytes is destroying my time."
CLIA requires 6-element competency documentation per staff member per test method. For a mid-size lab, that's thousands of records.
"We got cited for something I didn't even know was a requirement."
Regulatory changes happen constantly. Without a live intelligence layer, you're always a step behind.
"Before LabGuard, our inspection prep took three months of evenings and weekends. Last year we were inspection-ready by Tuesday morning — and we passed with zero deficiencies.
Three systems. One operating layer.
LabGuard isn't a template company. It's a live, AI-powered compliance infrastructure that becomes the operational backbone of your laboratory.
Compliance Intelligence
A live regulatory brain that monitors CLIA, CAP, COLA, and ISO 15189 — and automatically keeps your documentation current.
- ✓ 200+ dynamic SOPs, updated with every regulatory change
- ✓ Auto-triggered review cycles with acknowledgment tracking
- ✓ AI SOP Generator — custom SOPs in 3 minutes
- ✓ Version control with full audit trail
Operational Intelligence
The quality management system built specifically for clinical laboratories — not adapted from pharmaceutical software.
- ✓ 6-element competency management per analyte per staff member
- ✓ Westgard QC analysis with real-time pattern detection
- ✓ Proficiency testing calendar and response system
- ✓ CAPA workflows with effectiveness verification
AI Compliance Layer
Regulatory intelligence trained on 42 CFR Part 493, all CAP checklists, and 10,000+ real inspection deficiency records.
- ✓ Ask any compliance question — get a citation-backed answer
- ✓ Inspection Readiness Score with predictive deficiency analysis
- ✓ AI Reimbursement Optimizer — stop leaving money on the table
- ✓ Trained on your lab profile — not generic advice
Plans for every laboratory
No setup fees. No long-term contracts. Cancel anytime.
- ✓ 25+ dynamic waived testing SOPs
- ✓ Annual QC documentation system
- ✓ Inspection readiness checklist
- ✓ Staff competency tracking (5 staff)
- ✓ AI Compliance Q&A (25 queries/month)
- ✓ Regulatory update alerts
- ✓ 200+ dynamic SOPs, all specialties
- ✓ AI SOP Generator — unlimited
- ✓ Full 6-element competency management
- ✓ QC tracking with Westgard analysis
- ✓ CAPA workflow system
- ✓ AI Compliance Assistant — unlimited
- ✓ Inspection Readiness Predictor
- ✓ PT tracking & response system
- ✓ Everything in Professional
- ✓ CAP checklist management system
- ✓ LDT assay lifecycle management
- ✓ Multi-site synchronization
- ✓ Role-based access (5 roles)
- ✓ Executive compliance dashboard
- ✓ LIS/HIS integration APIs
- ✓ Dedicated onboarding + monthly call
Lab directors who stopped
fearing their inspectors.
"We went from dreading CAP inspections to actually looking forward to them. LabGuard's inspection readiness score was at 94% when our inspector arrived. Zero phase II deficiencies."
"The AI SOP Generator alone saved us 200+ hours. Our lab manager was writing SOPs manually every time we added a new test. Now it takes 4 minutes and the quality is better than what we had before."
"I'm a physician who opened a waived lab. I had no idea what CLIA actually required until I found LabGuard. The AI answered questions my consultant was charging $400/hour for. Worth 10x the subscription price."
Your next inspector visit
is closer than you think.
Join 500+ laboratories that have replaced compliance anxiety with operational confidence. 14-day free trial. No credit card required.
14-day free trial · No credit card · Cancel anytime · HIPAA-ready infrastructure