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Compliance documentation for CLIA- and CAP-regulated labs — without the enterprise price tag.
LabComplyx gives small and mid-size clinical laboratories a governed AI-assisted documentation layer for CAPA, deviations, SOP control, and inspection readiness. Every output requires human review. Every step produces an audit trail.
- CLIA-Aligned
- CAP Checklist Mapped
- 21 CFR Part 11
- ALCOA+ Audit Trail
- Human Review Required
Governed AI Drafting
AI drafts CAPA reports, deviation records, and SOP revisions. Your QA staff reviews and approves every output before it becomes a controlled document.
ALCOA+ Audit Trail
Every document carries a timestamped record of who drafted, who reviewed, and when. Built to satisfy 21 CFR Part 11 and CAP electronic records requirements.
Inspection Readiness
Gap reports mapped to specific CLIA and CAP checklist items. Know where your documentation stands before an inspector does.
How it works
Complete the Lab Health Score
Free 27-question self-assessment across 10 compliance domains. Results in 15 minutes.
We identify your highest-risk gaps
Domain-by-domain heat map. Top findings ranked by regulatory risk, each mapped to specific CLIA/CAP citations.
We build the workflows that fix them
Governed AI-assisted drafting with mandatory human review, ALCOA+ audit trail, and documentation that holds up.
Who it's for
The Lab Director Who Is Also the Quality Manager
You run a 5–50 person CLIA or CAP lab without a dedicated QA department. When CAP sends a deficiency notice, you're the one pulling records.
The QC Manager at a Specialty or Contract Testing Lab
You serve regulated clients who audit you. You need GxP-aligned documentation without paying $3K–$10K/month for an enterprise QMS.
The Solo Compliance Consultant
You support 5–15 lab clients and rebuild the same documentation from scratch for each one. LabComplyx is your infrastructure.
LabComplyx IS
- A governed AI-assisted documentation layer
- Structured workflows for CAPA, deviations, SOPs, inspection readiness
- Requires human review before any AI content is finalized
- ALCOA+ audit trail
- For small/midsized labs without dedicated QA
LabComplyx IS NOT
- A LIMS replacement
- A substitute for qualified QA judgment
- A guarantee of inspection passage
- An enterprise QMS (MasterControl, Qualio, Veeva)
- An FDA-cleared medical device
Who We Serve
Find your lab type
The same core value — governed, audit-ready documentation — adapted to your regulations, vocabulary, and inspection context.
Clinical & Diagnostic Labs
CLIA, CAP, inspection prep, competency records, and SOP discipline for clinical labs under inspection pressure.
Environmental & Testing Labs
ISO 17025 compliance, method documentation, QA records, and audit readiness for accredited testing labs.
Cannabis & Hemp Labs
State compliance, testing documentation, quality workflows, and lean team operations for cannabis labs.
Pharma & GxP Support
Validation, deviation documentation, and CAPA support for smaller pharma and GxP-regulated teams.
How It Works
The compliance layer between unsafe drafting and audit‑ready documentation.
LabComplyx is not a chatbot. It is a structured documentation workflow with compliance controls at every step — designed for regulated labs that can't afford to guess.
Bring in context
Upload your existing SOPs, deviations, CAPAs, or regulatory references. LabComplyx ingests them as structured inputs into governed workflows, not raw text.
Generate with guardrails
AI drafts are created inside governed workflows with compliance guardrails — no unsupported assertions, no off‑label claims, and clear traceability back to inputs.
Review and approve
Every output passes through a human review checkpoint before entering your quality record, with full audit trail, version history, and e‑signature support.
Workflow Governance Commitments
Deterministic, not generative
AI behavior is controlled by governed templates, structured prompts, and compliance rules — not open-ended generation.
Human sign-off required
Every document requires a human review checkpoint and sign-off before entering your quality record.
Audit trail
AI actions, reviewer decisions, and document versions are logged with timestamps.
How We Work With Your Lab
From first workflow to full governed layer
Most labs start with one workflow. Most stay because the governance model makes the next one easier.
Workflow Assessment
Find the right starting workflow and current-state gaps.
We map your highest-risk documentation workflows, identify where AI-assisted drafting would have the most impact, and deliver a prioritized governance roadmap your QA lead can act on.
Governance roadmap · Prioritized workflow list · Before/after framing
Pilot Workflow
Prove one governed workflow with real documents and measurable results.
We implement a single governed workflow — typically CAPA, SOP, or deviation — with real documents, human review checkpoints, and a clear before/after metric to validate the approach before expanding.
Live governed workflow · Human review checkpoints · Measured outcome
Core & Full Rollout
Expand governed workflows across your highest-risk documentation areas.
Once the pilot proves value, we roll governed workflows across your priority documentation areas — Core Rollout covers 2–3 workflow areas, Full Rollout covers 4–5 — with a practical governance model, training, and audit trail infrastructure in place.
Multi-workflow rollout · Team training · Ongoing governance layer
Add-ons & Fractional Support
Built for trust in governed workflows
Where generic AI creates risk, LabComplyx creates a defensible record.
LabComplyx focuses on governed workflows, human review, traceability, and audit-ready evidence — so every documentation output can be explained, exported, and defended.
- Every AI output requires human review before entering a quality record
- Audit trail with timestamped entries
- Designed for CLIA, CAP, ISO 17025, and GxP workflows
- No generic AI — governed prompts with compliance guardrails
- Works alongside your current QMS and LIMS — no rip-and-replace
- Documentation outputs are versioned, traceable, and exportable
Proof of governance — captured at every step
Governance & Trust FAQ
Regulatory accuracy, AI validation, audit trails, data integrity, and security — the questions QA leads and IT teams ask before trusting a compliance platform, answered with evidence.
Start with the free Lab Health Score — 15 minutes.
Gap report across 10 compliance domains. No sales call, no obligation.